BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-K (HUMAN MONOCLONAL) SERIES 2

    MDR report key: 963349 · Received December 14, 2007

    Report

    Report Number
    1034569-2007-00319
    Event Type
    Malfunction
    Date Received
    December 14, 2007
    Date of Event
    November 8, 2007
    Report Date
    December 3, 2007
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    103543 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    TESTED FOUR K+K+ AND FOUR K-K+ RED CELLS WITH RETURNED ANTI-K (HUMAN MONOCLONAL) SERIES 2, LOT 7C7523. THE EXPECTED REACTIVITY WAS OBSERVED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WITH ANTI-K. WHEN CROSSMATCHING A UNIT, INCOMPATIBILITY WAS OBSERVED. WHILE PHENOTYPING THE INCOMPATIBLE UNIT, IT TESTED AS K NEGATIVE. CUSTOMER REPEATED THE TESTING USING ANTI-K ADDING AN ADDITIONAL DROP OF REAGENT TO THE TUBE AND WAS ABLE TO OBSERVE A STRONGER REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-K (HUMAN MONOCLONAL) SERIES 2 BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 7C7523

    Patients

    Seq Age Sex Outcome Treatment
    1