MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-02-29 for COBAS? AMPLIPREP/COBAS? TAQMAN? HBV TEST, V2.0 CE-IVD 04894570190 manufactured by Roche Molecular Systems.
[9801409]
A customer reported that they had recently moved from the roche cobas ampliprep / cobas taqman (cap/ctm) hbv v2. 0 test to the abbott realtime system during parallel validation testing, they discovered that one patient sample had displayed result discrepancies with > 1 log titer differences between the two tests. The cap/ctm result was consistently lower than that generated with the abbott system for this sample. The investigation included sequencing analysis of two aliquots of the sample in question. The (b)(6) present in the samples was confirmed to be genotype e. Sequence obtained from the samples contains three mismatches to the downstream primer used in the cap/ctm hbv v2. 0 test, with one of the mismatches located near the 3' end of the primer. The mismatches observed to the downstream primer are likely to affect the performance of the cap/ctm hbv v2. 0 test and may lead to discrepant titers. As stated in the cap/ctm hbv v2. 0 package insert procedural limitations section, "though rare, mutations within the highly conserved region of the viral genome covered by the cobas ampliprep/cobas taqman hbv test, v2. 0 primers and/or probe may result in the under-quantitation of or failure to detect the virus. " in the intended use section it states "the results from the cobas ampliprep/cobas taqman hbv test, v2. 0 must interpreted within the context of all relevant clinical and laboratory findings. " (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[21352041]
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
[21416381]
A customer from the (b)(6) filed a complaint alleging that underquantitated results were generated with the cobas ampliprep/cobas taqman (cap/ctm) hbv v2. 0 test. Specifically, the customer alleged an underquantitated result was generated during validation of the abbott system. The customer has recently moved from the roche system to the abbott system for their diagnostic testing. As part of the validation they have gone back and retested patient samples on the abbott system that were initially tested on the roche system. As part of a single kit in parallel testing they discovered quite a few discrepancies i. E. >1 log differences between the assays. The samples in question were all taken from the same patient at different time points. Sequencing was performed by the customer and generated a result of genotype e. The samples were all stored frozen between initial and repeat test.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2012-00010 |
| MDR Report Key | 2472949 |
| Report Source | 01,05 |
| Date Received | 2012-02-29 |
| Date of Report | 2012-04-13 |
| Date of Event | 2010-11-24 |
| Date Mfgr Received | 2012-04-12 |
| Date Added to Maude | 2012-08-24 |
| 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 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 | 2012-02-29 |
| Catalog Number | 04894570190 |
| Lot Number | P00408 |
| Device Expiration Date | 2012-01-30 |
| 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 | 2012-02-29 |