MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-08-13 for COBAS TAQSCREEN MPX TEST 04584252190 manufactured by Roche Molecular Systems.
[2852070]
A customer site in the united states alleged that they generated discrepant results with the cobas s201 taqscreen mpx test. Specifically, the patient sample generated (b)(6) results with the cobas s201 taqscreen mpx test and (b)(6) results with an unknown serology test. The units were not released.
Patient Sequence No: 1, Text Type: D, B5
[10035329]
(b)(4): no failure detected and product performed within specification. No product or batch non-conformance was identified. Upon investigation there was no trend found in the field. Qc release data for p01607 was reviewed and the issue of discrepant results has not been observed. There have not been any manufacturing non-conformance reports for batch p01607. Retain testing of the complaint batch p01607 was tested for this case and generated valid and acceptable results. Although requested, a sample was not available from the customer to be sent for further investigation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[10172186]
The investigation into this reported issue is ongoing, and therefore, no conclusion can be drawn at this time. The conclusion of this investigation will be reported through a follow-up report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2012-00032 |
| MDR Report Key | 2693691 |
| Report Source | 05 |
| Date Received | 2012-08-13 |
| Date of Report | 2012-08-29 |
| Date of Event | 2012-08-29 |
| Date Mfgr Received | 2012-08-29 |
| Date Added to Maude | 2012-11-30 |
| 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 | VINCENT STAGNITTO |
| Manufacturer Street | 1080 US HWY 202S |
| Manufacturer City | BRANCHBURG NJ 088763733 |
| Manufacturer Country | US |
| Manufacturer Postal | 088763733 |
| Manufacturer Phone | 9082537569 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS TAQSCREEN MPX TEST |
| Generic Name | HEPATITIS VIRAL B DNA DETECTION; BLOOD SCREENING |
| Product Code | MKT |
| Date Received | 2012-08-13 |
| Catalog Number | 04584252190 |
| Lot Number | P01607 |
| Device Expiration Date | 2012-01-31 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Address | 1080 US HW 202S BRANCHBURG NJ 08876373 US 08876 3733 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-13 |