BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-A (MURINE MONOCLONAL) SERIES 1

    MDR report key: 778612 · Received November 3, 2006

    Report

    Report Number
    1034569-2006-00160
    Event Type
    Malfunction
    Date Received
    November 3, 2006
    Date of Event
    October 12, 2006
    Report Date
    November 2, 2006
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REC'D 10 VIALS OF ANTI-A (SERIES 1). VIALS A, B, E, F, G, AND H WERE REC'D UNOPENED. VIALS C, D, I, AND J WERE REC'D PREVIOUSLY OPENED. ALL VIALS CONTAIN PRODUCT WHICH APPEARS BLUE IN COLOR, WITH NO DISCOLORATION AND NO TURBIDITY OBSERVED. NO CLOTS, AGGLUTINATES, PARTICULATES OR LEAKING WERE OBSERVED. RETENTION TESTING WAS PERFORMED USING ANTI-A, LOT 101664 AND A1 CELLS, LOT 111564. HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH RETURNED (10 VIALS) AND RETENTION ANTI-A, LOT 101664 AND RETENTION A1 CELLS. RETENTION ANTI-A PERFORMED AS EXPECTED (4+ REACTIVITY). RETURNED VIALS A, B, D, E, F, G, AND H EXHIBITED 3+S TO 4+ REACTIVITY, VIAL I EXHIBITED 1+ TO 2+ REACTIVITY, VIAL C EXHIBITED 1+ REACTIVITY AND VIAL J WAS NONREACTIVE. DHR REVIEW REVEALED NO DEFICIENCIES. IT IS NOT POSSIBLE TO RULE OUT CONTAMINATION OF THE CUSTOMER'S PRODUCT AS A CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ABO DISCREPANCIES FOR PT SAMPLES TESTED ON THE GALILEO WHEN PERFORMING ABO/RH TESTING USING IMMUCOR ANTI-A, SERIES 1. REPEAT TESTING WAS PERFORMED USING MANUAL TUBE TESTING TO TEST A1 REFERENCE CELLS, LOT #111563. UNEXPECTED NEGATIVE REACTIONS WERE OBSERVED IN 4 OF 10 VIALS TESTED AND (4+) REACTIONS IN THE OTHER 6 VIALS. CUSTOMER STATES THIS LOT HAS BEEN IN USE SINCE 8/24/06 AND THEY HAVE NOT HAD ANY ISSUES PREVIOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-A (MURINE MONOCLONAL) SERIES 1 BLOOD GROUP REAGENT KSZ IMMUCOR * 101664

    Patients

    Seq Age Sex Outcome Treatment
    1 * REFERENCELLS, LOT #111563