MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-02-11 for IMMULITE 2000 0300002 manufactured by Siemens Healthcare Diagnostics Inc..
[19464151]
Discordant low hcg results were obtained on 3 patient samples. The discordant results were not reported to the physician. The samples were repeated on the lab's second immulite 2000 system (b)(4). The repeat results from (b)(4) were reported to the physician. Patient treatment was not altered or prescribed. There were no report of adverse health consequences due to the discordant hcg results.
Patient Sequence No: 1, Text Type: D, B5
[19615526]
A siemens healthcare field service engineer (fse) was sent to the customer site for instrument eval. Analysis of the instrument and the instrument data indicate that the cause for the discordant hcg results cannot be determined. After eval of the instrument, the fse replaced both probe assemblies, and decontaminated the fluidic and substrate systems. The instrument is performing within specs. No further eval of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[19742321]
Discordant low hcg results were obtained on 3 patient samples. The discordant results were not reported to the physician. The samples were repeated on the lab's second immulite 2000 system (b)(4). The repeat results from (b)(4) were reported to the physician. Patient treatment was not altered or prescribed. There were no report of adverse health consequences due to the discordant hcg results.
Patient Sequence No: 2, Text Type: D, B5
[19813225]
Discordant low hcg results were obtained on 3 patient samples. The discordant results were not reported to the physician. The samples were repeated on the lab's second immulite 2000 system (b)(4). The repeat results from (b)(4) were reported to the physician. Patient treatment was not altered or prescribed. There were no report of adverse health consequences due to the discordant hcg results.
Patient Sequence No: 2, Text Type: D, B5
[19883279]
A siemens healthcare field service engineer (fse) was sent to the customer site for instrument eval. Analysis of the instrument and the instrument data indicate that the cause for the discordant hcg results cannot be determined. After eval of the instrument, the fse replaced both probe assemblies, and decontaminated the fluidic and substrate systems. The instrument is performing within specs. No further eval of the device is required.
Patient Sequence No: 2, Text Type: N, H10
[20143338]
A siemens healthcare field service engineer (fse) was sent to the customer site for instrument eval. Analysis of the instrument and the instrument data indicate that the cause for the discordant hcg results cannot be determined. After eval of the instrument, the fse replaced both probe assemblies, and decontaminated the fluidic and substrate systems. The instrument is performing within specs. No further eval of the device is required.
Patient Sequence No: 2, Text Type: N, H10
[19604844]
Discordant low hcg results were obtained on 3 patient samples. The discordant results were not reported to the physician. The samples were repeated on the lab's second immulite 2000 system (b)(4). The repeat results from (b)(4) were reported to the physician. Patient treatment was not altered or prescribed. There were no report of adverse health consequences due to the discordant hcg results.
Patient Sequence No: 3, Text Type: D, B5
[19814073]
Discordant low hcg results were obtained on 3 patient samples. The discordant results were not reported to the physician. The samples were repeated on the lab's second immulite 2000 system (b)(4). The repeat results from (b)(4) were reported to the physician. Patient treatment was not altered or prescribed. There were no report of adverse health consequences due to the discordant hcg results.
Patient Sequence No: 3, Text Type: D, B5
[19883823]
A siemens healthcare field service engineer (fse) was sent to the customer site for instrument eval. Analysis of the instrument and the instrument data indicate that the cause for the discordant hcg results cannot be determined. After eval of the instrument, the fse replaced both probe assemblies, and decontaminated the fluidic and substrate systems. The instrument is performing within specs. No further eval of the device is required.
Patient Sequence No: 3, Text Type: N, H10
[20130494]
A siemens healthcare field service engineer (fse) was sent to the customer site for instrument eval. Analysis of the instrument and the instrument data indicate that the cause for the discordant hcg results cannot be determined. After eval of the instrument, the fse replaced both probe assemblies, and decontaminated the fluidic and substrate systems. The instrument is performing within specs. No further eval of the device is required.
Patient Sequence No: 3, Text Type: N, H10
| Report Number | 2247117-2010-00004 |
| MDR Report Key | 1613142 |
| Report Source | 05,06 |
| Date Received | 2010-02-11 |
| Date of Report | 2010-01-13 |
| Date of Event | 2010-01-13 |
| Date Mfgr Received | 2010-01-13 |
| Date Added to Maude | 2011-09-15 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA BARLETTA |
| Manufacturer Street | 511 BENEDICT AVENUE |
| 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 | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 |
| Generic Name | IMMUNO-ASSAY |
| Product Code | DGC |
| Date Received | 2010-02-11 |
| Model Number | NA |
| Catalog Number | 0300002 |
| 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 07835 US 07835 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-02-11 | |
| 2 | 0 | 2010-02-11 | |
| 3 | 0 | 2010-02-11 |