MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-02-08 for COBAS AMPLIPREP/COBAS TAQMAN HIV-1 03542998190 manufactured by Roche Molecular Systems, Inc..
[781040]
A customer using the product was experiencing frequent runs that had the low positive contro (lpc) failing due to being out-of-range low. They developed their own protocol that allowed results from the run to be reported if at least one of each of the control replicates were valid. A total of 120 patient samples from 5 invalid runs were reported. The patient treatment was not impacted since the customer reviews patient history to determine if the current results correlate with previous testing. In addition, some of the samples were retested and the repeat result showed good correlation to the initial result with less than 0. 2 log (b) (4) titer difference observed. Product labeling clearly indicates all data generated in the same run as with a failed control is to be considered invalid and the test repeated.
Patient Sequence No: 1, Text Type: D, B5
[8044745]
There is no evidence of product malfunction. An internal investigation is underway to determine the cause for the control falling out of range. The customer was advised to follow instructions for use of the test. Specifically the customer was advised that results from invalid runs should not be reported and that samples be retested and monitored against baseline titers if they were previously reported from invalid runs. (b) (4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2008-00004 |
| MDR Report Key | 996409 |
| Report Source | 05,07 |
| Date Received | 2008-02-08 |
| Date of Report | 2008-02-08 |
| Date Mfgr Received | 2008-01-28 |
| Date Added to Maude | 2009-12-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROBERT PIPOZZI |
| Manufacturer Street | 4300 HACIENDA DRIVE |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 9257308272 |
| Manufacturer G1 | ROCHE MOLECULAR SYSTEMS, INC. |
| Manufacturer Street | 1080 U.S. HWY. 202 |
| Manufacturer City | SOMERVILLE NJ 08876377 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08876 3771 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS AMPLIPREP/COBAS TAQMAN HIV-1 |
| Generic Name | HIV-1 NUCLEIC ACID TEST |
| Product Code | MTL |
| Date Received | 2008-02-08 |
| Catalog Number | 03542998190 |
| Lot Number | J08417 |
| Device Expiration Date | 2008-05-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC. |
| Manufacturer Address | BRANCHBURG NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-02-08 |