MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-11-03 for HIVAB HIV-1/HIV-2 (RDNA) EIA 3A77-68 manufactured by Abbott Laboratories.
[1247079]
The customer states that false positive results have been generated on one patient by the abbott (b) (6) (rdna) eia assay. On (b) (6) 2009, a female patient presented with weakness and dizziness. Testing with the abbott hivab (b) (6)/(b) (6) (rdna) eia assay generated weak repeat reactive results close to the assay cut-off. The sample was sent for (b) (6) testing, but the test was never performed and not followed up on at the time. The patient was seen again on (b) (6) 2009 and again generated similar weak repeat reactive results with the abbott (b) (6) (rdna) eia assay. This sample was sent for (b) (6) analysis and generated a non-reactive result. No treatment is documented as having been administered to the patient between (b) (6) and (b) (6) 2009.
Patient Sequence No: 1, Text Type: D, B5
[8360905]
(b) (4) this is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete. An investigation is in process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2009-01145 |
| MDR Report Key | 1519708 |
| Report Source | 05 |
| Date Received | 2009-11-03 |
| Date of Report | 2009-10-28 |
| Date of Event | 2009-05-06 |
| Date Mfgr Received | 2009-12-17 |
| Device Manufacturer Date | 2009-08-18 |
| Date Added to Maude | 2009-12-22 |
| 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 | NOEMI KONDOS RN, BSN |
| Manufacturer Street | 200 ABBOTT PARK ROAD DEPT. 09B9, AP50 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 8479375120 |
| Manufacturer G1 | ABBOTT LABORATORIES |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 60064350 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60064 3500 |
| 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 | IN VITRO DIAGNOSTIC TEST FOR THE DETECTION OF HIV-1 AND HIV-2 ANTIBODIES |
| Product Code | LRM |
| Date Received | 2009-11-03 |
| Catalog Number | 3A77-68 |
| Lot Number | 80175M100 |
| Device Expiration Date | 2009-11-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 60064350 US 60064 3500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-11-03 |