BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1030581 · Received April 16, 2008

    Report

    Report Number
    1415939-2008-00055
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    February 16, 2008
    Report Date
    March 18, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LRM
    PMA / PMN Number
    103385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A PT GENERATED A FALSE REACTIVE RESULT ON HIVAB HIV-1/HIV-2 (RDNA)EIA. THE PT HAD FOUR VIRAL IMMUNIZATIONS IN 2008 AND A BLOOD SPECIMEN WAS OBTAINED AFTER THE IMMUNIZATIONS. THE SAMPLE WAS TESTED THE FOLLOWING DAY AND GENERATED REPEAT REACTIVE RESULTS ON HIV-1/HIV-2 (RDNA EIA AND WAS INDETERMINATE ON WESTERN BLOT. ADD'L SAMPLES WERE OBTAINED FROM THIS PT ON FIVE DAYS LATER, AND THE FOLLOWING MONTH, BOTH GENERATING NONREACTIVE RESULTS ON HIV-1/HIV-2 (RDNA) EIA WHEN TESTED THE DAY AFTER COLLECTION. NO IMPACT TO PT MGMT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIVAB HIV-1/HIV-2 (RDNA) EIA EIA FOR DETECTION OF AB TO HIV I AND II LRM ABBOTT LABORATORIES NA 59546M100

    Patients

    Seq Age Sex Outcome Treatment
    1 NI COMMANDER PPC LIST #6208-01