MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2004-10-22 for AMPLICOR HIV-1 MONITOR TEST, V1.5 21118560018 manufactured by Roche Molecular Systems, Inc..
[686222]
Co rec'd a complaint pertaining to the amplicor hiv-1 monitor test, v1. 5. The customer reported that the hiv titers in the standard and ultra sensitive sample preparations did not correlate. Review of info contained in the complaint resulted in the determination by co. That potentially erroneous results could be obtained if the customer report is confirmed.
Patient Sequence No: 1, Text Type: D, B5
[8127825]
Co is performing investigations with clinical samples of known pedigree to determine if the customers observations are valid. However, as of the writing of this report, roche has not confirmed the customer's allegation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2004-00005 |
| MDR Report Key | 887710 |
| Report Source | 06,08 |
| Date Received | 2004-10-22 |
| Date of Report | 2004-10-21 |
| Date of Event | 2004-09-20 |
| Report Date | 2004-10-21 |
| Date Reported to Mfgr | 2004-09-20 |
| Date Mfgr Received | 2004-09-20 |
| Device Manufacturer Date | 2004-03-01 |
| Date Added to Maude | 2007-08-02 |
| 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 | AMPLICOR HIV-1 MONITOR TEST, V1.5 |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | MTL |
| Date Received | 2004-10-22 |
| Model Number | NA |
| Catalog Number | 21118560018 |
| Lot Number | F00707 |
| ID Number | NA |
| Device Expiration Date | 2005-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 865272 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC. |
| Manufacturer Address | 4300 HACIENDA DR. PLEASANTON CA 94588 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-10-22 |