MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,05 report with the FDA on 2009-03-04 for COBAS AMPLIPREP/COBAS TAQMAN HIV-1 TEST 03542998190 manufactured by Roche Molecular Systems.
[1066606]
.
Patient Sequence No: 1, Text Type: D, B5
[8217779]
The kit batches alleged in the complaint were investigated and no nonconformance was identified. The actual device was not provided by the customer for evaluation. In addition, a sequence analysis of the provided specimens was performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2009-00004 |
| MDR Report Key | 1328614 |
| Report Source | 02,05 |
| Date Received | 2009-03-04 |
| Date of Report | 2009-03-04 |
| Date of Event | 2008-04-30 |
| Date Mfgr Received | 2009-02-04 |
| Date Added to Maude | 2009-08-21 |
| 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 | MR ROBERT PIGOZZI |
| Manufacturer Street | 4300 HACIENDA DRIVE |
| Manufacturer City | PLEASANTON CA 945880900 |
| Manufacturer Country | US |
| Manufacturer Postal | 945880900 |
| Manufacturer Phone | 9257308272 |
| Manufacturer G1 | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Street | 1080 US 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 TEST |
| Generic Name | MONITOR, TEST, HIV-1 |
| Product Code | MTL |
| Date Received | 2009-03-04 |
| Catalog Number | 03542998190 |
| Lot Number | J08417 |
| Device Expiration Date | 2008-05-31 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Address | 1080 US HWY 202 SOMERVILLE NJ 08876377 US 08876 3771 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-03-04 |