BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 2143270 · Received June 28, 2011

    Report

    Report Number
    1034569-2011-00077
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 24, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE CALL WAS MADE. INSPECTED THE WASHER MODULE, CHECKED PBS VOLUMES. THE CHANNELS WERE NOTICEABLY UNEVEN AND COULDN'T BE CORRECTED BY CLEANING/STYLETTING MANIFOLD REPLACED MANIFOLD. CALIBRATED WASHER MODULE. RAN QC TEST ASSAY, CUSTOMER'S PQ PANEL (POOL_CELL ASSAY X8 SPECIMENS) AND RE-TESTED THE TWO SPECIMENS FROM THE SAME DONOR WITH BOTH REPORTING EXPECTED RESULTS. THE SYSTEM WAS TESTED AND PERFORMED WITHIN SPECIFICATIONS WITH NO PROBLEMS OBSERVED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED DISCREPANT RESULTS WHEN TESTING TWO SAMPLES FROM THE SAME DONOR ON THE GALILEO CMV ASSAY. BOTH SAMPLES HAD BEEN TESTED ON THE SAME GALILEO ON THE SAME CMV PLATE. ONE OF THE SAMPLES GAVE A NEGATIVE INTERPRETATION, WHILE THE OTHER SAMPLE GAVE A POSITIVE INTERPRETATION.

    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