BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-A (MURINE MONOCLONAL) SERIES 1

    MDR report key: 727006 · Received June 15, 2006

    Report

    Report Number
    1034569-2006-00037
    Event Type
    Malfunction
    Date Received
    June 15, 2006
    Date of Event
    May 16, 2006
    Report Date
    June 14, 2006
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH RETURNED AND RETENTION ANTI-A LOT 101660, IN-HOUSE DONOR SAMPLES AND THE CUSTOMER SAMPLES. EXPECTED REACTIVITY WAS OBSERVED WITH THE IN-HOUSE DONOR SAMPLES; THE TWO CUSTOMER SAMPLES DID NOT REACT. IT IS LIKELY THAT BOTH SAMPLES ARE A WEAK A SUBGROUP. THERE WAS NO TRANSFUSION OF INCOMPATIBLE BLOOD BASED ON THE RESULTS, HOWEVER, THE POTENTIAL FOR TRANSFUSION OF INCOMPATIBLE BLOOD EXISTS IF RED BLOOD CELLS OF AN A SUBGROUP WERE TRANSFUSED TO AN O RECIPIENT. THE INSERT FOR ANTI-A CONTAINS THE FOLLOWING LIMITATIONS: "NOTE: INCUBATION FOR 5-60 MINUTES AT 18-30C MAY BE NECESSARY TO ENHANCE THE REACTIVITY OF THE BLOOD GROUPING REAGENTS WITH SOME OF THE WEAK SUBGROUPS OF A AND B. CERTAIN SUBGROUPS OF A AND B MAY PRODUCE REACTIONS THAT ARE WEAKER THAN THOSE OBTAINED IWTH A OR B CELLS OF MOST RANDOM DONORS. DEPENDING ON THE SUBGROUP INVOLVED, SOME MAY APPEAR NON-REACTIVE IN DIRECT AGGLUTINATION TUBE, MICRO TITRATION PLATE OR SLIDE TESTS."

    Description of Event or Problem · 1

    UNEXPECTED NEGATIVE REACTION WAS OBSERVED WITH ANTI-A. IT DI DNOT REACT WITH WEAK A SUBGROUPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-A (MURINE MONOCLONAL) SERIES 1 BLOOD GROUP REAGENT KSZ IMMUCOR, INC. * 101660

    Patients

    Seq Age Sex Outcome Treatment
    1 *