MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2004-10-08 for COBAS AMPLICOR HIV-1 MONITOR TEST, V1.5 03155935018 manufactured by Roche Molecular Systems, Inc..
[671108]
Roche molecular systems, inc. Received a complaint pertaining to the cobras amplicor hiv-1 monitor test, v1. 5. In the complaint, the customer reported that hiv titers in the standard and ultra sensitive sample preparations did not correlate. Review and preliminary investigation lead to the determination that potentially erroneous results could be obtained if the customer report is confirmed.
Patient Sequence No: 1, Text Type: D, B5
[7808748]
Investigations have been conducted at the user site and at roche molecular systems, inc. These investigations addressed laboratory technique, sample handling and storage, assay variability and frequency of discordancy. As of the writing of this report, roche has not confirmed the report with samples of known pedigree. Additionally, the frequency of discordancy has not been confirmed to be different than that contained in the product's design history file and data contained in the product's pma filing. Roche molecular systems, inc. Is continuing to investigate this matter.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2004-00004 |
| MDR Report Key | 888725 |
| Report Source | 06,08 |
| Date Received | 2004-10-08 |
| Date of Report | 2004-10-07 |
| Date of Event | 2004-09-09 |
| Report Date | 2004-10-07 |
| Date Reported to Mfgr | 2004-07-22 |
| Device Manufacturer Date | 2004-04-01 |
| Date Added to Maude | 2007-08-03 |
| 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 | 3 |
| Manufacturer Contact | KAREN LONG |
| Manufacturer Street | 4300 HACIENDA DR. |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 9257308110 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS AMPLICOR HIV-1 MONITOR TEST, V1.5 |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | MTL |
| Date Received | 2004-10-08 |
| Model Number | NA |
| Catalog Number | 03155935018 |
| Lot Number | F01765 |
| ID Number | NA |
| Device Expiration Date | 2005-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 866148 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC. |
| Manufacturer Address | 4300 HACIENDA DR. PLEASANTON CA 94588 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other | 2004-10-08 |