MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-08-24 for COBAS? AMPLIPREP/COBAS? TAQMAN? HBV TEST, V2.0 CE-IVD 04894570190 manufactured by Roche Molecular Systems.
[2166022]
A customer from (b)(6) filed a complaint alleging that discrepant hbv results were generated for two samples with the cobas ampliprep/cobas taqman (cap/ctm) hbv v2. 0 test when compared to the versant bdna test. (b)(6). It is planned to obtain sequencing information for the sample. The other sample is addressed in mdr 2243471-2011-00076.
Patient Sequence No: 1, Text Type: D, B5
[9401880]
The issue is under investigation. No conclusions can be drawn at this time. The associated us product is (b)(4). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[9457521]
(b)(4): method: analysis of labeling and (review of design history data and analysis of raw data from the customer site). Result: device performed according to specifications. Conclusion: no failure detected and product performed within specification. No product or batch non-conformance was identified. Analysis of the raw data does not show any indication of an issue with the cobas ampliprep/ cobas taqman system (i. E. Curve anomalies, pipetting problems, etc. ). Upon investigation there was no trend found in the field. Qc release data for n11158 was reviewed and the issue of discrepant results has not been observed. There have not been any manufacturing non-conformance reports for batch n11158. The package insert for this test includes a correlation study between the cap-ctm hbv test and the versant hbv dna test. The study includes one sample with similarly discrepant results (log 2 for cap-ctm and log 5 for versant). Review of the design history file for this study shows that the study sample was sequenced and had no mismatches that would affect the cap-ctm test. The study sample also correlated well between cap-ctm, abbott, cobas amplicor and high pure tests. The study sample was retested with cap-ctm and the same results were confirmed. There are no additional conclusions made in the study regarding this discrepancy, however, it could be that the versant tests over quantifies this sample. No sample material was available from the customer for investigative testing to confirm the presence of any sequence mismatches or to further evaluation this issue. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2011-00077 |
| MDR Report Key | 2222065 |
| Report Source | 01,05 |
| Date Received | 2011-08-24 |
| Date of Report | 2011-07-26 |
| Date of Event | 2011-07-13 |
| Date Mfgr Received | 2011-09-01 |
| Date Added to Maude | 2011-09-23 |
| 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 | 2011-08-24 |
| Catalog Number | 04894570190 |
| Lot Number | N18322 |
| Device Expiration Date | 2012-03-30 |
| 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 HWY 202 BRANCHBURG NJ 08876373 US 08876 3733 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-24 |