BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 840323 · Received October 11, 2006

    Report

    Report Number
    1034569-2006-00144
    Event Type
    Malfunction
    Date Received
    October 11, 2006
    Date of Event
    September 19, 2006
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REALIZED THE PATIENT WAS TRANSFUSED MULTIPLE TIMES WITH NON-TYPE SPECIFIC UNITS AND IS AWARE OF GALILEO'S LIMITATION. THE OPERATOR MANUAL INDICATES: "THE GALILEO DOES NOT DIFFERENTIATE MIXED FIELD REACTIONS." THE INSTRUMENT IS PERFORMING AS EXPECTED. A KNOWN LIMITATION OF THE INSTRUMENT, RESULTING FROM TRANSFUSION OF NON-TYPE SPECIFIC UNITS, CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ABO DISCREPANCY ON A PATIENT SAMPLE RUN ON GALILEO. THE PATIENT IS HISTORICALLY AB POSITIVE, BUT TYPED B POSITIVE IN 2006. THE PATIENT WAS TRANSFUSED 6 UNITS OF RED BLOOD CELLS SINCE 29 DAYS EARLIER. TRANSFUSIONS WERE AS FOLLOWS: 2 UNITS OF O POSITIVE TWENTY FIVE DAYS LATER; 2 UNITS OF B POSITIVE 10 DAYS EARLIER; 1 UNIT OF A POSITIVE FIFTEEN DAYS EARLIER; 1 UNIT OF O POSITIVE ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALILEO KSZ KSZ IMMUCOR * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *