MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-10-02 for HIVAB HIV-1/HIV-2 (RDNA) EIA 3A77-90 manufactured by Abbott Laboratories.
[937312]
The account generated discrepant hiv-1/2 eia results on a donor. In 2008, the donor tested with reagent lot 64342m201. On three days later, the same specimen was accidentally run as an initial test with reagent lot 64544m101 generating a reactive result (0. 174 s/co, 0. 120=co). The specimen was repeated in duplicate with reagent with reactive results (0. 167, 0. 189 s/co, 0. 122=co). This specimen was drawn on three days prior to original date. The initial nonreactive eia result was reported but the unit was pulled prior to leaving the laboratory. No confirmatory testing was performed on this specimen. On that day, the donor returned to donate again without knowledge of the previous reactive donation. The specimen from the same day, tested eia reactive (0. 161 s/co, 0. 127=co and 0. 161, 0. 158 s/co, 0. 113=co). Additionally, the same day, specimen tested western blot negative and hiv-2 negative. The donor is no longer able to donate. Both units were destroyed. No other information is available about the donor. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[8100491]
Evaluation in process, no result or conclusion codes can be chosen. This is an initial report. An investigation is in process. A final report will be submitted when the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[19034830]
(b)(4). A review of complaint data along with a product labeling review determined that a product deficiency is not likely. Acceptance criteria were met for the complaint tracking and trending review. The issue of specimens that are initially and repeatedly reactive and negative or indeterminate on supplemental testing is addressed in the abbott (b)(6) package insert. The interpretation of results section of the package insert states: specimens found to be repeatedly reactive by abbott (b)(6) must be investigated by additional, more specific supplemental tests. Additionally, the interpretation of results of specimens found to be repeatedly reactive by abbott (b)(6) and negative or indeterminate on additional more specific supplemental testing is unclear; further clarification may be obtained by testing another specimen taken three to six months later. The investigation determined that the abbott (b)(6) is performing as intended and meeting its safety, effectiveness and label claims. The investigation team reviewed customer complaints to determine if others have experienced the issues encountered at the customer facility. The review of this data did not identify an increase in complaint activity for the issue observed at the account. The investigation team was not able to execute performance testing for these lots because both lots had exceeded their expiration date by the time the complaint was received. Refer to the interpretation of results section in the abbott (b)(6) package insert which states: specimens found to be repeatedly reactive by abbott (b)(6) must be investigated by additional, more specific supplemental tests. Additionally, the interpretation of results of specimens found to be repeatedly reactive by abbott (b)(6) and negative or indeterminate on additional more specific supplemental testing is unclear; further clarification may be obtained by testing another specimen taken three to six months later. This is a final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2008-00503 |
| MDR Report Key | 1180643 |
| Report Source | 05 |
| Date Received | 2008-10-02 |
| Date of Report | 2008-09-05 |
| Date of Event | 2008-05-24 |
| Date Mfgr Received | 2009-02-12 |
| Device Manufacturer Date | 2008-04-01 |
| Date Added to Maude | 2009-03-09 |
| 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. 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 | 2008-10-02 |
| Model Number | NA |
| Catalog Number | 3A77-90 |
| Lot Number | 62961M101 |
| ID Number | 64544M101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2008-10-02 |