MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-12-18 for COBAS TAQSCREEN MPX TEST US-IVD 04584252190 manufactured by Roche Molecular Systems.
[20272929]
A blood center in the us filed a complaint alleging that a false non-reactive cobas taqscreen mpx result was generated for one donor sample (b)(6) on (b)(6) 2013 when using the cobas taqscreen mpx test. The sample was tested in pools of 6 but was not tested individually in pools of 1. The donor was positive for (b)(6) serology (positive for both (b)(6) surface antigen and (b)(6) antibody). The donation was not released.
Patient Sequence No: 1, Text Type: D, B5
[20493700]
The investigation into this issue is on-going. The conclusion from the investigation will be provided through a follow-up report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2013-00037 |
| MDR Report Key | 3525958 |
| Report Source | 05 |
| Date Received | 2013-12-18 |
| Date of Report | 2013-11-21 |
| Date of Event | 2013-04-15 |
| Date Mfgr Received | 2013-11-21 |
| Date Added to Maude | 2014-03-31 |
| 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 US-IVD |
| Generic Name | HEPATITIS VIRAL B DNA DETECTION |
| Product Code | MKT |
| Date Received | 2013-12-18 |
| Catalog Number | 04584252190 |
| Lot Number | R01527 |
| Device Expiration Date | 2013-10-31 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2013-12-18 |