MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-03-18 for COBAS AMPLICOR / COBAS TAQMAN HIV-1 TEST, VERSION 2.0 05212308190 manufactured by Roche Molecular Systems.
[1954988]
A customer site in the us reported that discrepant results were generated during a comparison study with the cobas ampliprep / cobas taqman hiv-1 test, version 2. 0. Specifically, the customer indicated that the sample generated a log of (b)(6) when tested with version 1 of the cobas ampliprep / cobas taqman hiv-1 test and a log of (b)(6) when tested with the cobas ampliprep / cobas taqman hiv-1 test version 2.
Patient Sequence No: 1, Text Type: D, B5
[8835453]
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
[9076964]
(b)(4). Device performed according to specification, no failure detected and product within specification. The customer reported that discrepant results were generated for one sample during a comparison study with the cobas ampliprep/ cobas taqman (cap/ctm) hiv-1 test (version 1) and cobas ampliprep/ cobas taqman hiv-1 test, version 2. The results generated for the cap/ctm hiv-1 version 1 test were (b)(6). The cap/ctm hiv-1 test, version 2, generated results of (b)(6) for the same sample. (b)(4). Sequencing analysis was performed on the customer returned patient sample and generated the following results: (b)(4). For the cap/ctm hiv-1 test (version 1), there is a mismatch to the downstream primer that is likely to affect assay performance based on the location of the mismatch. For the cap/ctm hiv-1 version 2 test, mismatches to the gag downstream primer are likely to affect the (b)(4). However, there are no mismatches present under the ltr primers and probe. Therefore, no sequence related performance issues are expected for the cap/ctm hiv version 2 test. No product non-conformance was identified. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2011-00035 |
| MDR Report Key | 2023307 |
| Report Source | 05 |
| Date Received | 2011-03-18 |
| Date of Report | 2011-02-22 |
| Date of Event | 2011-01-22 |
| Date Mfgr Received | 2011-02-22 |
| Date Added to Maude | 2012-06-06 |
| 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 AMPLICOR / COBAS TAQMAN HIV-1 TEST, VERSION 2.0 |
| Generic Name | TEST, HIV DETECTION |
| Product Code | MTL |
| Date Received | 2011-03-18 |
| Catalog Number | 05212308190 |
| 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 | 2011-03-18 |