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 AMPLICOR HIV-MONITOR TEST, VL.5 * 03155935018 manufactured by Roche Molecular Systems, Inc..
[380928]
The customer is running the cobas amplicor hiv-1 monitor test, vl. 5 using the ultrasensitive sample preparation method using the qiagen 9604 to automate sample preparation. A total of 96 samples and controls are processed at one time and amplification and detection is performed on four separate cobas amplicor analyzers (24 samples/controls per analyzer with 12 samples/controls per a-ring). The customer runs one control per a-ring. The run of 96 samples is considered valid if one negative control, one low positive and one high positive control, one low postive and one high positive control are all valid. The customer reported that in one run of 96, 8 samples had invalid qs (quantitation standard) and that titer results for these samples were not reported. However, in the same run one of the controls had an invalid qs. The hiv-1 titer results for the other 80 samples processed in this run were reported out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2005-00012 |
| MDR Report Key | 592774 |
| Report Source | 05,06,07 |
| Date Received | 2005-04-11 |
| Date of Event | 2005-02-21 |
| Date Mfgr Received | 2005-02-23 |
| 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 | 9257308272 |
| 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-MONITOR TEST, VL.5 |
| Generic Name | IN VITRO DIAGNOSTIC DEVICE; NAT |
| Product Code | MTL |
| Date Received | 2005-04-11 |
| Model Number | * |
| Catalog Number | 03155935018 |
| Lot Number | F09527 |
| ID Number | * |
| Device Expiration Date | 2005-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 582628 |
| 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 |