BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1241304 · Received November 25, 2008

    Report

    Report Number
    1034569-2008-00575
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 24, 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

    PCANYWHERE WAS USED TO RETRIEVE THE INSTRUMENT IMAGES. REVIEW OF THE IMAGES SHOWED A FIBROUS CLOT IN THE WELL, GIVING THE WELL A POSITIVE APPEARANCE. FOLLOWED UP WITH CUSTOMER, SHE STATED THAT SHE HAD PULLED THE TUBE AND CHECKED FOR CLOTS. SHE STATED THAT THERE WASN'T A CLOT IN THE TUBE BUT THE SAMPLE WAS "STICKY". SAMPLE CONTAINED FIBRIN. CUSTOMER IS AWARE THAT SAMPLES THAT ARE CLOTTED OR CONTAIN FIBRIN SHOULDN'T BE USED FOR TESTING ON THE GALILEO. THE MISTYPE WAS CAUSED BY THE CLOT IN THE SAMPLE. THE GALILEO OPERATOR MANUAL INDICATES THE GALILEO CAN NOT DETECT VERY LARGE CLOTS; CLOTTED SAMPLES SHOULD NOT BE TESTED ON GALILEO.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A DONOR SAMPLE REPORTED AS AB POSITIVE ON THE GALILEO USING THE REFLEX FWD ASSAY. THE SAMPLE WAS A FIRST TIME DONOR AND HAD BEEN TESTED ON THE OLYMPUS PK PRIOR TO BEING TESTED ON THE GALILEO. THIS INTERPRETATION DIDN'T MATCH THE OLYMPUS PK, WHICH REPORTED THE SAMPLE AS 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