MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2010-12-16 for COBAS TAQSCREEN MPX TEST 4584244190 manufactured by Roche Molecular Systems.
[1823657]
A customer site in (b)(6) reported that a donor specimen generated a false non-reactive test result, for (b)(6), when tested with the cobas taqscreen mpx test. Specifically, the customer reported that the donor specimen was serology positive ((b)(6)) and generated non-reactive and reactive test results with the cobas taqscreen mpx test. The donation was rejected due to the positive serology test result.
Patient Sequence No: 1, Text Type: D, B5
[8805542]
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
[21870836]
(b)(4). Device performed according to specifications, no failure detected and product within specification. As part of the investigation conducted, viral load testing of the customer-returned donor sample (aliquot a) with the cobas ampliprep / cobas taqman (cap/ctm) hbv v2. 0 test generated a result of target not detected. Testing of aliquot b generated a qs_invalid result. Aliquot b sample was red in color which is typically seen with hemolyzed samples. (b)(4). The investigation determined that the discrepant mpx result is likely due to a (b)(4). No product or batch non-conformance was identified as: (b)(4). Table 2 from the package insert captures the analytical sensitivity of the cobas taqscreen test for hbv. (b)(4). Viral load testing of the customer-returned donor sample (aliquot a) with the cobas ampliprep / cobas taqman (cap/ctm) hbv v2. 0 test generated a result of target not detected. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2010-00048 |
| MDR Report Key | 1929695 |
| Report Source | 01,05 |
| Date Received | 2010-12-16 |
| Date of Report | 2010-12-02 |
| Date of Event | 2010-11-09 |
| Date Mfgr Received | 2010-12-02 |
| Date Added to Maude | 2012-01-06 |
| 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 | 2010-12-16 |
| Catalog Number | 4584244190 |
| 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 | 2010-12-16 |