BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1369646 · Received April 28, 2009

    Report

    Report Number
    1034569-2009-00132
    Event Type
    Malfunction
    Date Received
    April 28, 2009
    Date of Event
    April 3, 2009
    Report Date
    April 10, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED WITH DONORS OF KNOW ABO/RH TYPES WITH RETENTION ANTI-A, LOT 101685, ANTI-B, LOT 203240, MONOCLONAL CONTROL, LOT 492033, ANTI-D SERIES 4, LOT 504711 ON AN IN-HOUSE GALILEO. NO ABO DISCREPANCY WAS NOTED. RETENTION PRODUCTS PERFORMED AS EXPECTED. THE REAGENTS ARE THE SAME LOTS USED BY THE CUSTOMER AT THE TIME OF THE EVENT.INSTRUMENT IMAGES WERE REVIEWED. THE CUSTOMER'S OBSERVATIONS WERE CONFIRMED. THE GALILEO OPERATOR MANUAL STATES THAT FORWARD ONLY ABO-RH TESTING HAS A HIGHER RISK OF MISTYPE DUE 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 CALLED TO REPORT AN ABO MISTYPE ON THE GALILEO.

    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