BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FACTOR VIII ANTIBODY SCREEN

    MDR report key: 7706639 · Received July 20, 2018

    Report

    Report Number
    2183608-2018-00002
    Event Type
    Malfunction
    Date Received
    July 20, 2018
    Date of Event
    November 27, 2017
    Report Date
    November 27, 2017
    Manufacturer
    IMMUCOR GTI DIAGNOSTICS, INC.
    Product Code
    GGP
    UDI-DI
    10888234500001
    PMA / PMN Number
    K082205
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT (B)(4) WAS RECEIVED ON (B)(6) 2017 FOR FACTOR VIII ANTIBODY SCREEN (303283) LOT 3004682. THE CUSTOMER REPORTED THAT A (B)(6) YEAR OLD MALE PATIENT HAD FACTOR VIII ANTIBODY SCREEN ASSAY RESULTS THAT WERE NEGATIVE, AND THE LABORATORY'S BETHESDA ASSAY RESULTS WERE POSITIVE (2.4 TITER). FACTOR VII ANTIBODY SCREEN ASSAY RESULTS ARE ALSO DEPENDENT ON THE PROGRESSION OF ANTIBODY FORMATION AS WELL AS IF/WHEN FVIII THERAPY IS ADMINISTERED. THE PATIENT'S COURSE OF THERAPY WAS NOT AVAILABLE FROM THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549367 FACTOR VIII ANTIBODY SCREEN FACTOR VIII ANTIBODY SCREEN GGP IMMUCOR GTI DIAGNOSTICS, INC. 3004682 10888234500001

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR