BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKERS RAPID HIT AB PIFA TEST

    MDR report key: 8659260 · Received May 30, 2019

    Report

    Report Number
    MW5087059
    Event Type
    Injury
    Date Received
    May 30, 2019
    Report Date
    May 27, 2019
    Manufacturer
    AKERS BIOSCIENCE, INC.
    Product Code
    LCO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HIT AB TESTING DONE USING AKERS BIO SCIENCE HIT AB TEST WAS NEGATIVE, WHICH DELAYED THE DIAGNOSIS OF HIT AND HIT ELISA AB SENT OUT SIDE CAME BACK POSITIVE ALONG WITH SRA TESTING. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450336 AKERS RAPID HIT AB PIFA TEST PLATELET FACTOR 4 RADIO IMMUNOASSAY LCO AKERS BIOSCIENCE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening| S