BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-A (MURINE MONOCLONAL) GAMMA-CLONE

    MDR report key: 1759965 · Received July 16, 2010

    Report

    Report Number
    1034569-2010-00157
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    June 17, 2010
    Report Date
    July 15, 2010
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    STN 102129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PERFORMED HEMAGGLUTINATION TEST ON 4 KNOWN IN-HOUSE DONORS OF A1, A2 AND O GROUP TYPES AND WITH A1A2BO REFERENCELLS, LOT 115125 WITH RETENTION ANTI-A, LOT 104011-1. ALL IN-HOUSE DONORS EXHIBITED THE EXPECTED REACTIVITY. PERFORMED HEMAGGLUTINATION TEST ON 4 KNOWN IN HOUSE DONORS OF A1, A2 AND O GROUP TYPES AND WITH A1A2BO REFERENCELLS, LOT 115125 WITH RETURNED ANTI-A, LOT 104011-1. ALL IN-HOUSE DONORS EXHIBITED THE EXPECTED REACTIVITY. THE EVENT APPEARS TO BE SAMPLE RELATED AND USER ERROR IN NOT INITIALLY DETECTING THE WEAK REACTIVITY CANNOT BE RULED OUT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNEXPECTED NEGATIVE REACTION WHEN TESTING A SAMPLE WITH ANTI-A (MURINE MONOCLONAL) GAMMA-CLONE BLOOD GROUPING REAGENT. TESTING WAS PERFORMED ON A SAMPLE FROM A BABY. TESTING WITH ANTI-A,B RESULTED POSITIVE(1+). TESTING WAS REPEATED AND A WEAK POSITIVE REACTION RESULTED WITH THE ANTI-A AND A 2+REACTION RESULTED WITH THE ANTI-A,B.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-A (MURINE MONOCLONAL) GAMMA-CLONE BLOOD GROUPING REAGENT KSZ IMMUCOR 104011-1

    Patients

    Seq Age Sex Outcome Treatment
    1