MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-01-08 for COBAS AMPLIPREP/COBAS TAQMAN HIV-1 TEST 03542998190 manufactured by Roche Molecular Systems, Inc..
[776347]
Two customers using the product have experienced multiple test runs that had the low positive control (lpc) failing due to low out of range results. The customer reported out specimen results from these runs despite the instruction contained in the product labeling stating for a test run to be valid no run flags can appear for any of the three controls (high, low and negative).
Patient Sequence No: 1, Text Type: D, B5
[7931022]
An internal investigation is underway to determine the possible cause for the control falling out of range low. Customers have been advised to follow the instructions for use of the test, especially as it pertains to flagged control results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2008-00001 |
| MDR Report Key | 975856 |
| Report Source | 05 |
| Date Received | 2008-01-08 |
| Date of Report | 2007-12-11 |
| Date Mfgr Received | 2007-12-14 |
| Date Added to Maude | 2009-10-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROBERT PIGOZZI |
| Manufacturer Street | 4300 HACIENDA DR. |
| Manufacturer City | PLEASANTON CA |
| Manufacturer Country | US |
| Manufacturer Phone | 9257308272 |
| Manufacturer G1 | ROCHE MOLECULAR SYSTEMS, INC. |
| Manufacturer Street | 1080 U.S. HWY. 202 |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08876 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS AMPLIPREP/COBAS TAQMAN HIV-1 TEST |
| Generic Name | NONE |
| Product Code | MTL |
| Date Received | 2008-01-08 |
| Catalog Number | 03542998190 |
| Lot Number | J04456 |
| Device Expiration Date | 2008-03-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC. |
| Manufacturer Address | BRANCHBURG NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-08 |