MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-12-28 for COBAS AMPLISCREEN HBV TEST, US IVD 03599779190 manufactured by Roche Molecular Systems.
[15558136]
The customer reported that a donor sample that originally tested positive (on (b)(6)-2009) with the roche cobas taqscreen mpx test, us ivd and was (b)(6) antibody positive, tested negative for (b)(6) with the cobas ampliscreen (b)(6) test, us-ivd (note: the cobas ampliscreen (b)(6) test, us-ivd was being used for resolution testing. ). The customer indicated that the donor blood units were not released based on the roche cobas taqscreen mpx test, us ivd results.
Patient Sequence No: 1, Text Type: D, B5
[15885721]
No conclusion can be drawn at this time as the investigation into this issue is ongoing. Once additional information is available, a follow-up medical device report will be submitted. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2009-00018 |
| MDR Report Key | 1564889 |
| Report Source | 05 |
| Date Received | 2009-12-28 |
| Date of Report | 2009-11-30 |
| Date of Event | 2009-11-10 |
| Date Mfgr Received | 2010-03-23 |
| Device Manufacturer Date | 2009-05-04 |
| Date Added to Maude | 2010-10-06 |
| 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 AMPLISCREEN HBV TEST, US IVD |
| Generic Name | HEPATITIS VIRAL B DNA DETECTION |
| Product Code | MKT |
| Date Received | 2009-12-28 |
| Catalog Number | 03599779190 |
| Lot Number | M04731 |
| Device Expiration Date | 2010-06-30 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2009-12-28 |