BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PF4 IGG

    MDR report key: 5766760 · Received July 1, 2016

    Report

    Report Number
    2183608-2016-00002
    Event Type
    Malfunction
    Date Received
    July 1, 2016
    Date of Event
    June 9, 2016
    Report Date
    June 10, 2016
    Manufacturer
    IMMUCOR GTI DIAGNOSTICS, INC.
    Product Code
    LCO
    PMA / PMN Number
    K071781
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT (PR # (B)(4)) RECEIVED ON 06-10-2016, WHERE CUSTOMER INFORMED ABOUT UNEXPECTED NEGATIVE RESULTS WITH PF4 IGG ASSAY (HAT45G) LOT 3003584 FOR ASSAY RUN ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421164 PF4 IGG PF4 IGG LCO IMMUCOR GTI DIAGNOSTICS, INC. NA 3003584

    Patients

    Seq Age Sex Outcome Treatment
    1