MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2005-06-14 for COBAS AMPLICOR HIV-1 MONITOR TEST V1.5 US IVD 03155935018 manufactured by Roche Molecular Systems.
[428021]
Customer reports sporadic occurrences where the performance of the quantitation standard (qs) is inconsistent. Customer cites a specific example of an hiv titer discrepancy of 0. 69 log when the same plasma sample was tested twice using the cobas amplicor hiv-1 monitor test v1. 5. The initial test used kit lot f12735 and resulted in a titer of 622,000 c/ml. The repeat test used kit lot g00166 and resulted in a titer of 125,000 c/ml. Quantitation standard (qs) values on both tests were within specification, but the value on the original run had a much lower qs value than the value on the repeat test. Results from the repeat test were more consistent with the pt history and course of treatment. No change in treatment and course of treatment was initiated due to the initial hiv-1 titer result. Customer reports that this discrepancy occurs only with the standard test. The ultrasensitive test, run with the same kits as the standard test, showed no discrepancies.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2005-00020 |
| MDR Report Key | 639048 |
| Report Source | 06,07 |
| Date Received | 2005-06-14 |
| Date of Report | 2005-06-14 |
| Date of Event | 2005-05-11 |
| Date Mfgr Received | 2005-05-11 |
| Device Manufacturer Date | 2005-01-01 |
| Date Added to Maude | 2005-10-05 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | KAREN MCCULLOUGH |
| Manufacturer Street | 1080 US HIGHWAY 202 |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082537610 |
| 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 AMPLICOR HIV-1 MONITOR TEST V1.5 US IVD |
| Generic Name | IN VITRO DIAGNOSTIC TEST NAT |
| Product Code | MTL |
| Date Received | 2005-06-14 |
| Model Number | NA |
| Catalog Number | 03155935018 |
| Lot Number | F12735 |
| ID Number | * |
| Device Expiration Date | 2005-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 628595 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| 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 | 1. Other | 2005-06-14 |