MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-06-08 for IMMULITE 2000 030002 manufactured by Siemens Healthcare Diagnostics Inc..
[20631430]
Discordant multiple assay results were obtained on multiple patients samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 1, Text Type: D, B5
[20828134]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[20779754]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 2, Text Type: D, B5
[20852036]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 2, Text Type: N, H10
[20809640]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 3, Text Type: D, B5
[21036083]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 3, Text Type: N, H10
[20679033]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 4, Text Type: D, B5
[20895741]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 4, Text Type: N, H10
[20680167]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 5, Text Type: D, B5
[21036950]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 5, Text Type: N, H10
[20780188]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 6, Text Type: D, B5
[20854502]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 6, Text Type: N, H10
[20780191]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 7, Text Type: D, B5
[21036954]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 7, Text Type: N, H10
[20662482]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 8, Text Type: D, B5
[20854505]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 8, Text Type: N, H10
[20775218]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 9, Text Type: D, B5
[21036956]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 9, Text Type: N, H10
[20775220]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 10, Text Type: D, B5
[20854507]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 10, Text Type: N, H10
[20663590]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 11, Text Type: D, B5
[21036958]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 11, Text Type: N, H10
[20663591]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 12, Text Type: D, B5
[20896665]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 12, Text Type: N, H10
[20663592]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 13, Text Type: D, B5
[21080496]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 13, Text Type: N, H10
[20663593]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 14, Text Type: D, B5
[20854510]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 14, Text Type: N, H10
[20663594]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 15, Text Type: D, B5
[21037922]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 15, Text Type: N, H10
[20663595]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 16, Text Type: D, B5
[20897589]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 16, Text Type: N, H10
[20663596]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 17, Text Type: D, B5
[21080499]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 17, Text Type: N, H10
[20664725]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 18, Text Type: D, B5
[20846625]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 18, Text Type: N, H10
[20664726]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 19, Text Type: D, B5
[21037925]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 19, Text Type: N, H10
[20664727]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 20, Text Type: D, B5
[20897592]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 20, Text Type: N, H10
[20664728]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 21, Text Type: D, B5
[21080502]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 21, Text Type: N, H10
[20664729]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 22, Text Type: D, B5
[20846628]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 22, Text Type: N, H10
[20664730]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 23, Text Type: D, B5
[21037928]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 23, Text Type: N, H10
[20664731]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 24, Text Type: D, B5
[20897595]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 24, Text Type: N, H10
[20664732]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 25, Text Type: D, B5
[21080505]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 25, Text Type: N, H10
[20664733]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 26, Text Type: D, B5
[20846631]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 26, Text Type: N, H10
[20664734]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 27, Text Type: D, B5
[21037931]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 27, Text Type: N, H10
[20665921]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 28, Text Type: D, B5
[20897598]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 28, Text Type: N, H10
[20665922]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 29, Text Type: D, B5
[21067562]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 29, Text Type: N, H10
[20780200]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 30, Text Type: D, B5
[20883992]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 30, Text Type: N, H10
[20665923]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 31, Text Type: D, B5
[21037933]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 31, Text Type: N, H10
[20780201]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 32, Text Type: D, B5
[20846634]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 32, Text Type: N, H10
[20665924]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 33, Text Type: D, B5
[21067563]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 33, Text Type: N, H10
[20775222]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 34, Text Type: D, B5
[20883993]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 34, Text Type: N, H10
[20665925]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 35, Text Type: D, B5
[21039010]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 35, Text Type: N, H10
[20775223]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 36, Text Type: D, B5
[20847185]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 36, Text Type: N, H10
[20665926]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 37, Text Type: D, B5
[21067564]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 37, Text Type: N, H10
[20775224]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 38, Text Type: D, B5
[20883994]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 38, Text Type: N, H10
[20665927]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 39, Text Type: D, B5
[21039011]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 39, Text Type: N, H10
[20775225]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 40, Text Type: D, B5
[20847186]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 40, Text Type: N, H10
[20665928]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 41, Text Type: D, B5
[21067565]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 41, Text Type: N, H10
[20775226]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 42, Text Type: D, B5
[20883995]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 42, Text Type: N, H10
[20665929]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 43, Text Type: D, B5
[21039012]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 43, Text Type: N, H10
[20775227]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 44, Text Type: D, B5
[20847187]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 44, Text Type: N, H10
[20665930]
Discordant multiple assay results were obtained on multiple patient's samples. The samples were repeated and the correct results were reported. Patient treatment was prescribed for two patients. There were no reports of adverse health consequences as a result of the discordant results.
Patient Sequence No: 45, Text Type: D, B5
[21067566]
User error: a siemens healthcare technical support engineer (tse) analyzed the instrument data and determined that the cause of the discordant results were due to the operator running the instrument without the required water supply. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 45, Text Type: N, H10
| Report Number | 2247117-2009-00019 |
| MDR Report Key | 1408900 |
| Report Source | 05,06 |
| Date Received | 2009-06-08 |
| Date of Report | 2009-05-27 |
| Date of Event | 2009-04-22 |
| Date Mfgr Received | 2009-05-27 |
| Date Added to Maude | 2011-03-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA BARLETTA |
| Manufacturer Street | 511 BENEDICT AVE. |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242299 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | 62 FLANDERS BARTLEY ROAD |
| Manufacturer City | FLANDERS NJ 07836 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07836 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 |
| Generic Name | IMMUNO-ASSAY ANALYZER |
| Product Code | DGC |
| Date Received | 2009-06-08 |
| Model Number | NA |
| Catalog Number | 030002 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-06-08 | |
| 2 | 0 | 2009-06-08 | |
| 3 | 0 | 2009-06-08 | |
| 4 | 0 | 2009-06-08 | |
| 5 | 0 | 2009-06-08 | |
| 6 | 0 | 2009-06-08 | |
| 7 | 0 | 2009-06-08 | |
| 8 | 0 | 2009-06-08 | |
| 9 | 0 | 2009-06-08 | |
| 10 | 0 | 2009-06-08 | |
| 11 | 0 | 2009-06-08 | |
| 12 | 0 | 2009-06-08 | |
| 13 | 0 | 2009-06-08 | |
| 14 | 0 | 2009-06-08 | |
| 15 | 0 | 2009-06-08 | |
| 16 | 0 | 2009-06-08 | |
| 17 | 0 | 2009-06-08 | |
| 18 | 0 | 2009-06-08 | |
| 19 | 0 | 2009-06-08 | |
| 20 | 0 | 2009-06-08 | |
| 21 | 0 | 2009-06-08 | |
| 22 | 0 | 2009-06-08 | |
| 23 | 0 | 2009-06-08 | |
| 24 | 0 | 2009-06-08 | |
| 25 | 0 | 2009-06-08 | |
| 26 | 0 | 2009-06-08 | |
| 27 | 0 | 2009-06-08 | |
| 28 | 0 | 2009-06-08 | |
| 29 | 0 | 2009-06-08 | |
| 30 | 0 | 2009-06-08 | |
| 31 | 0 | 2009-06-08 | |
| 32 | 0 | 2009-06-08 | |
| 33 | 0 | 2009-06-08 | |
| 34 | 0 | 2009-06-08 | |
| 35 | 0 | 2009-06-08 | |
| 36 | 0 | 2009-06-08 | |
| 37 | 0 | 2009-06-08 | |
| 38 | 0 | 2009-06-08 | |
| 39 | 0 | 2009-06-08 | |
| 40 | 0 | 2009-06-08 | |
| 41 | 0 | 2009-06-08 | |
| 42 | 0 | 2009-06-08 | |
| 43 | 0 | 2009-06-08 | |
| 44 | 0 | 2009-06-08 | |
| 45 | 0 | 2009-06-08 |