BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 3113388 · Received May 15, 2013

    Report

    Report Number
    1034569-2013-00081
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 19, 2013
    Report Date
    May 15, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE ECHO RESULT FILES FOR THE NEGATIVE ANTIBODY SCREEN SHOWED THAT CELL II APPEARED TO HAVE A FUZZY CELL BUTTON. THE CUSTOMER WAS ASKED TO CLEAN THE WASH MANIFOLD AND REPEAT TESTING. POSITIVE RESULTS WERE OBTAINED IN ALL THREE TEST WELLS. CONTROLS PERFORMED AS EXPECTED. THE INSTRUMENT IS OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE REACTIVITY ON THE ANTIBODY SCREENING ASSAY ON GALILEO ECHO M01258.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215381 GALILEO ECHO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR