MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2005-04-11 for COBAS AMLICOR HIV-1 MONITOR TEST, V1.5 * 03155935018 manufactured by Roche Molecular Systems, Inc..
[401621]
The customer reported that a false-positive result was generated in 2005 for a "hiv-1 negative, healthy" individual with the cobas amplicor hiv-1 monitor test, v1. 5, lot f03811. The customer further indicated that another false negative result was obtained for another false negative result was obtained for another individual in 2004 with lot e05757. For both samples. Hiv-1 titers for 2000-3000 copies/ml were obtained. Both individuals had been previously found to be hiv-1 negative using a screening test as a prerequisite to participation in an hiv-1 vaccine trial. The individual had not received trial vaccines at the time of testing. Upon re-draw of each individual about one week after the initial test and processing of the fresh samples using the same lot s of the cobas amplicor hiv-1 monitor test, the hiv results were < 50 iu/ml, i. E. , below the limit of detection of the test. The hiv-1 controls from each of the respective test kits during the runs were valid and met specifications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2005-00013 |
| MDR Report Key | 592784 |
| Report Source | 05,06,07 |
| Date Received | 2005-04-11 |
| Date of Event | 2005-02-28 |
| Date Mfgr Received | 2005-03-03 |
| Date Added to Maude | 2005-04-20 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | ROBERT PIGOZZI |
| Manufacturer Street | 1080 US HIGHWAY 202 SOUTH |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9257308271 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS AMLICOR HIV-1 MONITOR TEST, V1.5 |
| Generic Name | IN VITRO DIAGNOSTIC DEVICE; NAT |
| Product Code | MTL |
| Date Received | 2005-04-11 |
| Model Number | * |
| Catalog Number | 03155935018 |
| Lot Number | F03811 |
| ID Number | * |
| Device Expiration Date | 2005-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 582638 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC. |
| Manufacturer Address | * BRANCHBURG NJ 08876 US |
| Baseline Brand Name | COBAS AMPLICOR HIV-MONITOR TEST, VL.5 |
| Baseline Generic Name | IN VITRO DIAGNOSTIC DEVICE; NAT |
| Baseline Model No | * |
| Baseline Catalog No | 03155935018 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-04-11 |