BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1367500 · Received April 23, 2009

    Report

    Report Number
    1034569-2009-00154
    Event Type
    Malfunction
    Date Received
    April 23, 2009
    Date of Event
    March 26, 2009
    Report Date
    April 21, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER NOTICED THAT THE FLATFIELD WAS DIRTY; THE MIRROR AND LIGHT DIFFUSER WERE CLEANED. FWD_ABORH TESTING WAS PERFORMED WITH IN-HOUSE DONOR SAMPLES OF KNOWN ABO/RH TYPES, USING RETENTION ANTI-B SERIES 3 LOT 203252, ON THE IN-HOUSE GALILEO. NO ABO DISCREPANCIES WERE OBSERVED. THE GALILEO OPERATOR MANUAL STATES THAT FORWARD ONLY ABO-RH TESTING HAS A HIGHER RISK OF MISTYPE DO TO THE ABSCENCE OF THE REVERSE TYPE RESULTS. 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 AN ABO DISCREPANCY ON THE GALILEO. ON THE FWD_ABO ASSAY, A DONOR UNIT SEGMENT TYPED AS AB NEGATIVE, BUT THE DONOR IS A KNOWN A NEGATIVE DONOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1