BEUDAMED
    FDA Adverse Event Other Summary report: N

    HAVAB-M

    MDR report key: 1905810 · Received November 23, 2010

    Report

    Report Number
    MW5018251
    Event Type
    Other
    Date Received
    November 23, 2010
    Report Date
    November 8, 2010
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LOL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INCREASED INCIDENCE OF POSITIVES AND FALSE POSITIVES USING ARCHITECT HAVAB-M COMPARED TO AXSYM HAVAB-M. A <1% GRAYZONE/POSITIVE USING AXSYM HAVAB-M. AN 8.8% GRAYZONE/POSITIVE USING ARCHITECT HAVAB-M. OF 13 INITIALLY POSITIVE/GRAYZONE RESULTS, 3 REPEATED AS NEGATIVE ON THE ARCHITECT. TWO WERE NOT RETESTED ON AXSYM. EIGHT REPEATED AS POSITIVE/GRAYZONE ON THE ARCHITECT BUT WERE NEGATIVE BY THE AXSYM METHOD. A 62% FALSE POSITIVES COMPARING AXSYM TO ARCHITECT. DATES OF USE: #1: (B)(6) 2010; #2: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: VIRAL HEPATITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAVAB-M HEPATITIS A IGM LOL ABBOTT LABORATORIES ARCHITECT I1000SR 82584Q100
    2 HAVAB-M HEPATITIS A IGM LOL ABBOTT LABORATORIES * 86006Q100
    3 HAVAB-M HEPATITIS A IGM LOL ABBOTT LABORATORIES * 88077Q100

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other