MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-02-07 for COBAS? AMPLIPREP/COBAS? TAQMAN? HBV TEST, V2.0 CE-IVD 04894570190 manufactured by Roche Molecular Systems.
[20918289]
A customer from south korea filed a complaint alleging that discrepant (b)(6) results were generated with the cobas ampliprep/cobas taqman (cap/ctm) (b)(6) v2. 0 test. Specifically, the customer ran one patient sample twice with the cobas ampliprep/cobas taqman (cap/ctm) (b)(6) v2. 0 test and generated target not detected results for the first run and 90 iu/ml for the second run. Both runs were ran with the same draw of patient sample. The customer did not run controls on each rack as indicated for the protocol in the package insert.
Patient Sequence No: 1, Text Type: D, B5
[21149181]
No product or batch non-conformance was identified. Analysis of the growth curve for the sample did not indicate any anomalies that would contribute to the discrepant results. Upon investigation there was no trend found in the field. The complaint allegation was not observed during qc release testing. There have not been any manufacturing non-conformance reports for batch (b)(4). No sample material was available from the customer for investigative testing. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2012-00008 |
| MDR Report Key | 2440839 |
| Report Source | 01,05 |
| Date Received | 2012-02-07 |
| Date of Report | 2012-01-10 |
| Date of Event | 2012-01-10 |
| Date Mfgr Received | 2012-01-10 |
| Date Added to Maude | 2012-08-15 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | VINCENT STAGNITTO |
| Manufacturer Street | 1080 US HWY 202 |
| Manufacturer City | BRANCHBURG NJ 088763733 |
| Manufacturer Country | US |
| Manufacturer Postal | 088763733 |
| Manufacturer Phone | 9082537569 |
| Manufacturer G1 | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Street | 1080 US HWY 202 |
| Manufacturer City | BRANCHBURG NJ 08876373 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08876 3733 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS? AMPLIPREP/COBAS? TAQMAN? HBV TEST, V2.0 CE-IVD |
| Generic Name | HEPATITIS VIRAL B DNA DETECTION |
| Product Code | MKT |
| Date Received | 2012-02-07 |
| Catalog Number | 04894570190 |
| Lot Number | P00408 |
| Device Expiration Date | 2012-01-30 |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Address | 1080 US HWY 202 BRANCHBURG NJ 08876373 US 08876 3733 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-07 |