BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMA-CLONE ANTI-D (MONOCLONAL BLEND)

    MDR report key: 1062616 · Received June 23, 2008

    Report

    Report Number
    1034569-2008-00205
    Event Type
    Malfunction
    Date Received
    June 23, 2008
    Date of Event
    May 30, 2008
    Report Date
    June 20, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102131 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT RETURN SAMPLE OR PRODUCT. THE NATURE OF THE SAMPLE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED POSITIVE REACTIONS WITH GAMMACLONE ANTI-D, AT THE IMMEDIATE SPIN PHASE(IS) WHEN TESTING 3 PATIENT SAMPLES THAT WERE PREVIOUSLY TYPED AS WEAK D NEGATIVE WITH ANOTHER LOT OF GAMMACLONE ANTI-D. METHODOLOGY IS TUBE TESTING. NO ADVERSE REACTIONS OR TRANSFUSIONS OCCURRED AS A RESULT OF THE UNEXPECTED POSITIVE REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMA-CLONE ANTI-D (MONOCLONAL BLEND) BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. DMB71-3

    Patients

    Seq Age Sex Outcome Treatment
    1