BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1010503 · Received March 13, 2008

    Report

    Report Number
    1034569-2008-00058
    Event Type
    Malfunction
    Date Received
    March 13, 2008
    Date of Event
    February 12, 2008
    Report Date
    March 7, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE CALL WAS MADE. REPLACED SAMPLE PROBE 4 AND REAGENT PROBE. THE WASHER FLOW RATE FOR ALL FOUR PUMPS AND RESIDUAL VOLUME MET SPECIFICATIONS. FOLLOWING THE REPAIRS, THE INSTRUMENT FUNCTIONS AS EXPECTED. REFLEXFWD TESTING WAS PERFORMED ON AN IN-HOUSE GALILEO WITH CUSTOMER'S RETURNED DONOR SAMPLE USING RETENTION ANTI-A, LOT 101664, ANTI-B SERIES 3, LOT 203231, AND ANTI-D SERIES 4, LOT 504697. CUSTOMER'S SAMPLE TYPED AS A POSITIVE. REFLEXABO TESTING WAS PERFORMED ON AN IN-HOUSE GALILEO WITH CUSTOMER'S RETURNED DONOR SAMPLE AND IN-HOUSE DONOR SAMPLES USING RETENTION ANTI-A, LOT 101664, ANTI-B SERIES 3, LOT 203231, AND ANTI-D SERIES 4, LOT 504697. ALL IN-HOUSE DONOR SAMPLES TYPED AS EXPECTED. THE RETURNED SAMPLE WAS INTERPRETED AS INV POSITIVE. THE SAMPLE FORWARD TYPED AS GROUP A (4+ REACTIVITY WITH ANTI-A AND NEGATIVE WITH ANTI-B). INVALID RESULTS WERE REPORTED WITH A1 CELLS (EMPTY OR TOO DENSE WELLS). PLASMA EXHIBITED 4+ HEMOLYSIS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THREE MISTYPED DONOR SAMPLES ON GALILEO DURING ONE WEEK IN REFLEX ABO ASSAY. THE INSTRUMENT TYPED THE DONORS AS AB POSITIVE AND REPEAT TESTING SHOWED TYPE A POSITIVE.

    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