BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIVAB HIV-1/HIV-2 (RDNA) EIA

    MDR report key: 1180643 · Received October 2, 2008

    Report

    Report Number
    1415939-2008-00503
    Event Type
    Malfunction
    Date Received
    October 2, 2008
    Date of Event
    May 24, 2008
    Report Date
    September 5, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LRM
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    (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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIVAB HIV-1/HIV-2 (RDNA) EIA IN VITRO DIAGNOSTIC TEST FOR THE DETECTION OF HIV-1 AND HIV-2 ANTIBODIES LRM ABBOTT LABORATORIES NA 62961M101

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PPC LIST 6208-01, (B)(6) LOT 64342M201| PPC LIST 6208-01, (B)(6) LOT 64342M201