MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-03-19 for IMMULITE 2000 030002 manufactured by Siemens Healthcare Diagnostics Inc..
[15539692]
Discordant hcg and prg results were obtained on a patient sample. The discordant results were reported to the physician. The samples were repeated in triplicate on (b)(6) 2010. The repeat results were reported to the physician. The initial and repeat samples were all from the same tube. The patient stopped the use of medicines which are necessary for her pregnancy. There were no report of adverse health consequences due to the discordant hcg and progesterone results.
Patient Sequence No: 1, Text Type: D, B5
[15842801]
A siemens healthcare field service engineer (fse) was sent to the customer site for instrument evaluation. Analysis of the instrument and the instrument data indicate that the cause for the discordant hcg and prg results was a malfunction of the reagent pipettor. The instrument was repaired. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2010-00011 |
| MDR Report Key | 1640446 |
| Report Source | 05,06 |
| Date Received | 2010-03-19 |
| Date of Report | 2010-02-22 |
| Date of Event | 2010-02-18 |
| Date Mfgr Received | 2010-02-22 |
| Date Added to Maude | 2010-12-09 |
| 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 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 | 2010-03-19 |
| 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 07835 US 07835 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-03-19 |