BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1080698 · Received July 25, 2008

    Report

    Report Number
    1034569-2008-00263
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 25, 2008
    Report Date
    July 10, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REACTIVITY OF THE C AND JKA ANTIGENS WAS CONFIRMED ON RETENTION CAPTURE-R READY SCREEN, LOT X225. THIS LOT WAS USED BY THE CUSTOMER ON GALILEO. THE CUSTOMER DID NOT RETURN PRODUCT OR SAMPLE FOR INVESTIGATION. IT IS NOT POSSIBLE TO RULE OUT SAMPLE AS A CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED MISSED ANTIBODIES ON THE GALILEO, ON 2 PATIENT SAMPLES. ONE PATIENT HAD A HISTORY OF ANTI-C THE OTHER A HISTORY OF ANTI-JKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALILEO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1