MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-12-13 for HIVAB HIV-1/HIV-2 (RDNA) EIA 3A77-90 manufactured by Abbott Laboratories.
[19956662]
The account noticed an increase of repeat reactive rates for lot 55347m201. Out of 18,496 donors, the account generated a repeat reactive rate of 0. 13%. The account stated their threshold is 0. 10%. The account stated, the previous reagent lot was fine. The account processing using the commander fpc, ppc and di. The repeatedly specimens test negative. The results were not reported outside of the laboratory. No impact to pt management was reported.
Patient Sequence No: 1, Text Type: D, B5
[20114721]
(investigation results are pending). This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2007-00265 |
| MDR Report Key | 962761 |
| Report Source | 05 |
| Date Received | 2007-12-13 |
| Date of Report | 2007-11-14 |
| Date of Event | 2007-11-14 |
| Date Mfgr Received | 2007-11-14 |
| Device Manufacturer Date | 2007-07-01 |
| Date Added to Maude | 2008-05-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR. DAVID BARCH, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK RD. |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479379328 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HIVAB HIV-1/HIV-2 (RDNA) EIA |
| Generic Name | EIA FOR DETECTION OF AB TO HIV I AND II |
| Product Code | LRM |
| Date Received | 2007-12-13 |
| Model Number | NA |
| Catalog Number | 3A77-90 |
| Lot Number | 55347M201 |
| ID Number | NA |
| Device Expiration Date | 2007-12-09 |
| 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 | 970622 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK RD. ABBOTT PARK IL 600643500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-13 |