MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-04-25 for COBAS AMPLISCREEN HBV TEST 03599779190 manufactured by Roche Molecular Systems.
[16915939]
A customer in the us filed a complaint alleging that result discrepancies were generated for one patient sample with the cobas ampliscreen (cas) (b)(6) test in two separate runs as well as discrepancies when compared with eia testing with ortho and prism platforms. The cas (b)(6) test generated reactive and (b)(6) results in two runs. The eia testing with ortho generated a (b)(6) result. The eia testing with prism generated a reactive result. The donor sample was rejected and not released for donation.
Patient Sequence No: 1, Text Type: D, B5
[17089452]
A definitive conclusion cannot be drawn at this time, as the investigation into this issue is ongoing. The outcome of this investigation will be communicated through a follow-up report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[34940052]
Date of report may 21, 2014. Date of receipt by manufacturer may 21, 2014. Follow up report 1. Device evaluated by manufacturer yes. Result: device performed according to specification; conclusion: no failure detected and product within specifications. The complaint alleged that result discrepancies were generated for one patient sample with the cobas ampliscreen (cas) (b)(6) test in two separate runs as well as discrepancies when compared with eia testing with ortho and prism platforms. The cas (b)(6) test generated reactive and non-reactive results in two runs. The eia testing with ortho generated a non- reactive result. The eia testing with prism generated a reactive result. The donor sample was rejected and not released for donation. Although requested, no sample was available for further investigation; without investigating the complaint sample, the root cause for the discrepant results cannot be identified. It is possible that the discrepant results seen between the cas test runs could be due to the presence of a low hbv viral titer that is near the lod of the cas test. However this cannot be confirmed. Retain testing of cas complaint batch generated valid acceptable results. No false non-reactive results were generated during testing. All results met qc release validation and acceptance criteria. These results confirm the complaint kit batch is performing as intended (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2014-00009 |
| MDR Report Key | 3772187 |
| Report Source | 05 |
| Date Received | 2014-04-25 |
| Date of Report | 2014-05-21 |
| Date of Event | 2014-03-18 |
| Date Mfgr Received | 2014-05-21 |
| Date Added to Maude | 2014-06-19 |
| 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 |
| Generic Name | HBV NUCLEIC ACID AMPLIFICATION AND DETECTION |
| Product Code | MKT |
| Date Received | 2014-04-25 |
| Catalog Number | 03599779190 |
| Lot Number | S07522 |
| Device Expiration Date | 2014-07-31 |
| 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 | 2014-04-25 |