BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANOSCREEN I II & III

    MDR report key: 1012807 · Received March 17, 2008

    Report

    Report Number
    1034569-2008-00048
    Event Type
    Malfunction
    Date Received
    March 17, 2008
    Date of Event
    February 20, 2008
    Report Date
    March 10, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT RETURN PRODUCT OR SAMPLE FOR INVESTIGATION TESTING. THE INTEGRITY OF THE PRE-TRANSFUSION SAMPLE AND TECHNICAN ERRORS CAN NOT BE RULED OUT AS A CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER RAN AN ANTIBODY SCREEN ON A PATIENT WITH KNOWN ANTI-K USING PANOSCREEN LOT 53435. CELL I REACTED AS EXPECTED (KELL+ CELL). THE PATIENT WAS TRANSFUSED 2 UNITS OF RED CELLS THAT WERE COMPATIBLE AT AHG PHASE AND KELL NEGATIVE. THE PATIENT HAD SUFFERED A TRANSFUSION REACTION TO INCLUDE FEVER, CHILLS, AND LOWER BACK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PANOSCREEN I II & III REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. 53435

    Patients

    Seq Age Sex Outcome Treatment
    1 Other