BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 878774 · Received July 10, 2007

    Report

    Report Number
    1034569-2007-00164
    Event Type
    Malfunction
    Date Received
    July 10, 2007
    Date of Event
    June 12, 2007
    Report Date
    July 10, 2007
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK960019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER ALSO REPORTED CENTRIFUGE ERRORS. A SERVICE CALL WAS MADE. ADJUSTMENTS WERE MADE AND THE INSTRUMENT PERFORMED AS EXPECTED. THE CUSTOMER ALSO CHANGED THE LOT OF ANTI-A REAGENT USED FOR TESTING AND THE INSTRUMENT PERFORMED AS EXPECTED. CUSTOMER RETURNED TWO VIALS OF ANTI-A (MURINE MONOCLONAL) SERIES 1 FOR INVESTIGATION TESTING. FWD_ABO TESTING WAS PERFORMED ON AN IN-HOUSE GALILEO WITH RETURNED VIALS OF ANTI-A, LOT 101673; RETENTION ANTI-B (MURINE MONOCLONAL) SERIES 3, LOT 203225, RETENTION ANTI-D (MONOCLONAL BLEND) SERIES 4, LOT 504692, AND RETENTION MONOCLONAL CONTROL, LOT 492026 USING DONOR SEGMENTS. ONE SEGMENT WAS FLAGGED AS "CLOT DETECTED" DURING TESTING USING RETURNED VIAL "B" OF ANTI-A. ALL OTHER SEGMENTS WERE INTERPRETED AS EXPECTED WITH BOTH RETURNED VIALS OF ANTI-A, LOT 101673. NO ABO DISCREPANCY WAS OBSERVED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ABO MISTYPES ON FORWARD ABO RETYPES FOR DONOR SAMPLES TESTED ON THE GALILEO. CUSTOMER STATED THE DONOR SEGMENTS ARE KNOWN A, RH POSITIVE AND THEY ARE BEING REPORTED BY THE GALILEO AS O, RH POSITIVE. CUSTOMER STATES THAT THE DONOR SEGMENTS WERE REPEATED ON THE GALILEO AND THE EXPECTED ABO RESULTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR