BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENT ANTI-A

    MDR report key: 4179786 · Received October 17, 2014

    Report

    Report Number
    9610824-2014-00056
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    July 15, 2014
    Report Date
    August 14, 2014
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMNH
    Product Code
    QHR
    UDI-DI
    07611969950065
    PMA / PMN Number
    125219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663802 BLOOD GROUPING REAGENT ANTI-A SERACLONE ANTI-A QHR BIO-RAD MEDICAL DIAGNOSTICS GMNH 8304140-09 07611969950065

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SERACLONE ANTI-A, LOT 8324150-09, EXP. 06/04/2015