BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1202603 · Received October 21, 2008

    Report

    Report Number
    1034569-2008-00515
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    September 29, 2008
    Report Date
    October 20, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DID NOT HAVE SAMPLE TO RETURN FOR INVESTIGATION TESTING. THE OPERATOR MANUAL STATES THAT FORWARD ONLY ABO-RH TESTING HAS A HIGHER RISK OF MISTYPE DUE TO THE ABSENCE OF REVERSE TYPE RESULTS. HAZARDOUS MISTYPES MAY OCCUR. FOR THIS REASON, ABO-RH RESULTS SHOULD ALWAYS BE COMPARED TO THE PATIENT OR DONOR'S HISTORY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ABO DISCREPANCIES ON GALILEO USING REFLEXFWD ABO ASSAY WITH CORD BLOOD SAMPLES. PATIENTS THAT ARE A POSITIVE RESULTED AS O POSITIVE ON THE GALILEO.

    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