MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-03-17 for COBAS TAQMAN/COBAS AMPLIPREP HIV-1 TEST 03542998190 manufactured by Roche Molecular Systems, Inc..
[1486839]
A customer in the us reported that they received an overquantified patient result with the cap-ctm hiv-1 assay as compared with the previous results obtained with cobas amplicor hiv-1 monitor test (ca-him). The customer data showed that the patient's results with the ca-him were (b)(4) from (b)(6) 2005 to (b)(6) 2007. With the cap-ctm hiv-1 assay, the patient results are (b)(4). There was a test run reported with the cap-ctm hiv-1 assay which generated a result of (b)(4) for this patient, which is higher than typically expected it was stated in the complaint that there was a change in patient treatment made, but it is unknown if this was due to obtaining the result of (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[8595667]
It is expected that there will be instances in which the cap/ctm hiv-1 test yields measureable titers for patient samples that had previously been undetected or less than the limit of detection with the ca-him test. In these cases, it has been determined that the cap-ctm hiv-1 assay is performing as intended. For the higher than expected result of (b)(4), it is plausible that this result may have been a true "blip" in viral load, which is a known phenomenon that can occur when monitoring hiv-1 patients. Further information regarding this result was requested by the customer, but not provided. Without any further information being provided, it is not possible to assess whether the result generated may have been expected
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2010-00008 |
| MDR Report Key | 1633272 |
| Report Source | 05 |
| Date Received | 2010-03-17 |
| Date of Report | 2010-02-22 |
| Date of Event | 2010-02-22 |
| Date Mfgr Received | 2010-02-22 |
| Date Added to Maude | 2011-12-23 |
| 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 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS TAQMAN/COBAS AMPLIPREP HIV-1 TEST |
| Generic Name | TEST, HIV, DETECTION |
| Product Code | MKT |
| Date Received | 2010-03-17 |
| Model Number | 03542998190 |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC. |
| Manufacturer Address | 1080 US HWY 202 BRANCHBURG NJ 08876373 US 08876 3733 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-03-17 |