MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-08-31 for COBAS AMPLIPREP/COBAS AMPLICOR HIV-1 MONITOR 03309401018 manufactured by Roche Molecular Systems, Inc..
[719905]
A customer using the product was experiencing frequent runs that had the low positive control(lpc) failing due to being out-of-range low. Product labeling clearly indicates all data generated in the same run as with a failed control is to be considered invalid and the test repeated. During the course of the investigation into the lpc failure, it was determined the customer had reported approximately 147 invalid patient results to the physician along with a baseline disclaimer. Statement that these results were from a new assay.
Patient Sequence No: 1, Text Type: D, B5
[8123045]
There is no evidence of product malfunction. An internal investigation is underway to determine the cause for the control falling out of range. The customer was advised to follow instructions for use of the test. Specifically, the customer was advised that results from invalid runs should not be reported and that adding 1 log titer to the manufacturer determined control ranges is not acceptable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2007-00004 |
| MDR Report Key | 906949 |
| Report Source | 05,07 |
| Date Received | 2007-08-31 |
| Date of Report | 2007-08-31 |
| Date of Event | 2007-07-24 |
| Date Mfgr Received | 2007-08-14 |
| Date Added to Maude | 2007-11-06 |
| 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 | ROBERT PIGOZZI |
| Manufacturer Street | 4300 HACIENDA DR |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 9257308272 |
| Manufacturer Street | 1080 U.S. 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 AMPLICOR HIV-1 MONITOR |
| Generic Name | HIV-1 NUCLEIC ACID TEST |
| Product Code | MTL |
| Date Received | 2007-08-31 |
| Catalog Number | 03309401018 |
| Lot Number | J03876 |
| Device Expiration Date | 2008-12-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 904941 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC. |
| Manufacturer Address | BRANCHBURG NJ 08876 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-08-31 |