BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FACTOR VIII ANTIBODY SCREEN

    MDR report key: 3902584 · Received May 9, 2014

    Report

    Report Number
    2183608-2014-00001
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 6, 2014
    Manufacturer
    IMMUCOR GTI DIAGNOSTICS, INC.
    Product Code
    GGP
    PMA / PMN Number
    BK082205
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINT WAS RECEIVED (CMP-216) WHICH DESCRIBED THAT THE FACTOR VIII ANTIBODY SCREEN (F8S) ASSAY RESULTS WERE NEGATIVE (NEG) AND THE LABORATORY'S IN-HOUSE (B)(6) ASSAY RESULTS WERE POSITIVE. THE ORDERING PHYSICIAN WAS EXPECTING (B)(6) RESULTS ( UNITS - BU) AND CONTACTED LAB WHEN THEY DID NOT RECEIVE THE BU RESULTS. THE LABORATORIES TESTING PARADIGM WAS TO TEST SAMPLES ON THE F8S KIT AND IF POSITIVE RESULTS (POS) WERE OBTAINED, THEN THE SAMPLE WAS REFLUXED TO THE (B)(6) ASSAY. THE INITIAL CUSTOMER NOTIFICATION WAS PROVIDED TO MANUFACTURER ON (B)(6 )2014. AFTER MULTIPLE REQUESTS OF CUSTOMER, SAMPLES WERE SENT ON (B)(6) 2014 TO MANUFACTURER. INTERNAL TESTING SHOWED THAT THE CONCERNED LOT OF PRODUCT WAS PERFORMING AS EXPECTED WHEN USING INTERNAL WELL-CHARACTERIZED SAMPLES. THE (B)(6) ASSAY IS IN INTERNAL LAB DEVELOPED TEST. THE LABORATORY HAS CHANGED THEIR TESTING PARADIGM DUE TO THIS INFORMATION TO REFLUX SAMPLES TO THE (B)(6) ASSAY IF F8S IS LESS THAN 20 PERCENT ACTIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282244 FACTOR VIII ANTIBODY SCREEN FACTOR VIII ANTIBODY SCREEN GGP IMMUCOR GTI DIAGNOSTICS, INC. NA 3001285

    Patients

    Seq Age Sex Outcome Treatment
    1 NA