MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-03-24 for HIVAB HIV-1/HIV-2 (RDNA) EIA 3A77-78 manufactured by Abbott Laboratories.
[819465]
The account noticed an increased hiv-1/2 eia reactive rate processed on the commander ppc that did not confirm positive. The account stated a total of 8 specimens tested hiv-1/2 eia reactive but nucleic acid testing (nat), western blot and hiv-2 negative. The field service engineer was requested for the commander ppc for possible system contamination. After service was received on the commander ppc, one more patient tested hiv-1/2 eia repeatedly reactive but nat, western blot and hiv-2 negative. No specific patient data is available. Most of the reactive hiv-1/2 eia results were generated from high school students. No impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[7997300]
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
[8133755]
Corrected information: during the investigation, the causative agent changed from the analyzer, commander ppc list 6208-01 to the reagent, abbott hivab hiv-1/hiv-2(rdna)eia, list 3a77. The initial mdr report was filed using manufacturer's site number 1628664 for the commander ppc. Since the causative agent has changed the final mdr should use manufacturer's site number 1415939 for abbott hivab hiv-1/hiv-2(rdna)eia, list 3a77. Once a manufacturer's report number is generated all subsequent information is reported under that number. Because the initial mdr used manufacturer's site 1628664, the final mdr will also use this number. The investigational testing along with a review of complaint data determined that a product deficiency is not likely. Acceptance criteria were met for the complaint tracking and trending review. Patient discrepant result testing of file kit material indicated that the results of the testing were inconclusive. All eleven return patient specimens gave repeated reactive results when tested with the hivab hiv-1/hiv-2 (rdna) eia assay. The samples were sent to laboratory for further evaluation; and these results were determined to be either negative, indeterminate or inconclusive. The issue of specimens that are initially and repeatedly reactive and negative or indeterminate on supplemental testing is addressed in the abbott hivab hiv-1/hiv-2 (rdna) eia package insert. The interpretation of results section of the package insert states: "specimens found to be repeatedly reactive by abbott hivab hiv-1/hiv-2 (rdna) eia must be investigated by additional, more specific supplemental tests. " additionally, it states: "the interpretation of results of specimens found to be repeatedly reactive by abbott hivab hiv-1/hiv-2 (rdna) eia 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. "investigation:a complaint tracking and trending review was performed to determine if there were any trends related to the complaint under investigation or any additional issues related to the complaint. The acceptance criteria were met. The review of this data did not identify any problems. Specifically, there was no increase in the number of complaints related to an increase in initial reactive rates and repeat reactive rates while using the reagent lot numbers in question. The returned specimens were evaluated using a kit of lot 59024m200 from abbott inventory. The results of the patient specimens were found to be repeatedly reactive at the abbott facility. Further evaluation of the samples was performed and unfortunately the results were inconclusive. As a result, there was insufficient information available to determine if the samples were falsely positive on abbott hivab hiv-1/hiv-2(rdna) eia assay. Although the investigation team did not find any product deficiency, abbott will take further action by referring the customer to the abbott hivab hiv-1/hiv-2 (rdna) eia package insert. The "interpretation of results" section indicates "specimens found to be repeatedly reactive by hivab hiv-1/hiv-2 (rdna) eia must be investigated by additional, more specific supplemental tests. If also found to be reactive with these tests, the specimens are considered positive for antibodies to hiv-1 and/or hiv-2. The interpretation of results of specimens found to be repeatedly reactive by hivab hiv-1/hiv-2 (rdna) eia 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. " additionally, our "limitations of procedure" section indicates, "it is recommended that repeatedly reactive specimens be investigated by an additional more specific, or supplemental test. "based on the overall investigation, the abbott hivab hiv-1/hiv-2 (rdna) eia assay is performing acceptably. Although abbott cannot provide a specific reason for the observed increase in initial reactive rates and repeat reactive rates, we are continuing to monitor this assay for product issues in our ongoing effort to provide the highest quality diagnostic products and support. This is a final report.
Patient Sequence No: 1, Text Type: N, H10
[8291721]
(b)(4). Upon retrospective review, it was discovered that date received by manufacturer on the initial report was listed as (b)(6) 2006 was incorrect. The correct date received by manufacturer on the initial report should be listed as (b)(6) 2008. Evaluation listed as na due to follow-up report to correct information for initial report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2008-00076 |
| MDR Report Key | 1022522 |
| Report Source | 05 |
| Date Received | 2008-03-24 |
| Date of Report | 2008-02-26 |
| Date of Event | 2008-02-26 |
| Date Mfgr Received | 2009-07-10 |
| Device Manufacturer Date | 2007-12-05 |
| Date Added to Maude | 2009-09-21 |
| 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 | 2008-03-24 |
| Model Number | NA |
| Catalog Number | 3A77-78 |
| Lot Number | 59024M200 |
| ID Number | 59196M100 |
| Device Expiration Date | 2008-04-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2008-03-24 |