BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PF4 IGG

    MDR report key: 4437559 · Received January 16, 2015

    Report

    Report Number
    2183608-2015-00001
    Event Type
    Malfunction
    Date Received
    January 16, 2015
    Date of Event
    December 29, 2014
    Report Date
    January 7, 2015
    Manufacturer
    IMMUCOR GTI DIAGNOSTICS
    Product Code
    GWG
    PMA / PMN Number
    K070781
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TWO PATIENT SAMPLES WERE TESTED USING IMMUCOR GTI DIAGNOSTICS ASSAY PF4 IGG (K071781). THE SAMPLE RESULTS WERE POSITIVE. THE SAMPLES WERE RETESTED USING A REPLACEMENT WASH BUFFER PROVIDED BY THE MANUFACTURER. THE SAMPLE RESULTS WERE NEGATIVE. CONFIRMATORY TESTING WAS PERFORMED USING THE SEROTONIN RELEASE ASSAY (SRA). THE SRA IS A LABORATORY DEVELOPED TEST WHICH IS COMMONLY USED AS A CONFIRMATION ASSAY. THE CUSTOMER HAS CONFIRMED THAT PATIENT CARE WAS NOT AFFECTED DUE TO THE INITIAL FALSE POSITIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40909 PF4 IGG PF4 IGG GWG IMMUCOR GTI DIAGNOSTICS HAT45G 3002074

    Patients

    Seq Age Sex Outcome Treatment
    1 NA