MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-12-18 for COBAS AMPLIPREP/COBA TAQMON HIV-1 TEST 03542998190 manufactured by Roche Molecular Systems, Inc..
[18224814]
The laboratory was performing a study to switch from the cobas ampliprop/coabs amplicor hiv-1 monitor test (cap/ca him) to the cobas ampliprep/cobas tagman hiv-1 test (cap/ctm hiv). During the comparison one sample produces discrepant results >2. 0 log10 hiv titer. The cap/ca results on 26,000copies/ml initially and 46,000 copies/ml on repeat testing. The cap/ctm hiv results were 59 copies/ml.
Patient Sequence No: 1, Text Type: D, B5
[18342163]
An investigation is in progress to get more details regarding the incident. Sample material has been identified to be sent for sequencing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2007-00007 |
| MDR Report Key | 965768 |
| Report Source | 05 |
| Date Received | 2007-12-18 |
| Date of Report | 2007-12-10 |
| Date Mfgr Received | 2007-12-02 |
| Date Added to Maude | 2007-12-26 |
| 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 PIGOZZI |
| 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/COBA TAQMON HIV-1 TEST |
| Generic Name | HIV NUCLEIC ACID TEST REAGENT |
| Product Code | MTL |
| Date Received | 2007-12-18 |
| Catalog Number | 03542998190 |
| Lot Number | H14702 |
| Device Expiration Date | 2007-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 937566 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC. |
| Manufacturer Address | BRANCHBURG NJ 08876 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-18 |