BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKERS BIOSCIENCES RAPID PIFA HIT ALO TESTING

    MDR report key: 8658542 · Received May 30, 2019

    Report

    Report Number
    MW5087039
    Event Type
    Injury
    Date Received
    May 30, 2019
    Report Date
    May 27, 2019
    Manufacturer
    AKERS BIOSCIENCES, INC.
    Product Code
    LCO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AKERS BIOSCIENCE PIFA ANTI PF4 HIT ANTIBODY TESTING CAME BACK NEGATIVE, WHICH DELAYED THE DIAGNOSIS OF THE RARE SPONTANEOUS HIT, REPEAT WAS ALOS NEGATIVE, BUT LATER HIT ELISA AND SRA WAS POSITIVE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449093 AKERS BIOSCIENCES RAPID PIFA HIT ALO TESTING PLATELET FACTOR 4 RADIOIMMUNOASSAY LCO AKERS BIOSCIENCES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Disability