MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-07-21 for HIVAB HIV-1/HIV-2 (RDNA) EIA 3A77-90 manufactured by Abbott Laboratories.
[1105763]
The account noticed increased reactive rates for reagent lot 76225m102 during may and june 2009. Between 22,000 - 23,000 samples were processed with repeatedly reactive samples that did not confirm with western blot and confirmatory tests. No specific testing or patient data was provided for the repeatedly reactive samples. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[8367363]
(b)(4) - evaluation - a review of the complaint data was performed to assess the performance of the assay. The complaint activity for the observed issue was normal and the issue is adequately addressed in the product labeling. In order to evaluate the performance of the reagent lot, and to ensure that the product continues to meet performance expectations, an evaluation using 450 known negative serum specimens was performed using lot 76225m100* from our inventory. The testing met the acceptance criteria, thus indicating the lot continues to meet labeling claims for clinical specificity. *note: the base lot (i. E. , lot 76225m100) contains the same active components as the sublot (i. E. , lot 76225m102). The investigation team reviewed complaint and quality records to determine if other customers had experienced similar issues that might warrant further investigation. This review did not show any unusual activity related to the customer observations. The issue of samples that are initially and repeatedly reactive, and negative or indeterminate on supplemental testing is addressed in the abbott (b)(6) eia package insert. This investigation indicates that the abbott (b)(4) eia is effective and is performing acceptably. No deficiency identified.
Patient Sequence No: 1, Text Type: N, H10
[8433288]
No method, results or conclusion code can be chosen at this time. 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 | 1415939-2009-01089 |
| MDR Report Key | 1417035 |
| Report Source | 05 |
| Date Received | 2009-07-21 |
| Date of Report | 2009-07-01 |
| Date Mfgr Received | 2009-09-10 |
| Device Manufacturer Date | 2009-04-09 |
| Date Added to Maude | 2009-10-02 |
| 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 | 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 | 2009-07-21 |
| Catalog Number | 3A77-90 |
| Lot Number | 76225M102 |
| Device Expiration Date | 2009-07-08 |
| 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 | 2009-07-21 |