BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 3123865 · Received May 22, 2013

    Report

    Report Number
    1034569-2013-00086
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 22, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE ECHO RESULT FILES FOR THE NEGATIVE ANTIBODY SCREEN SHOWED THAT ALL THREE CELLS APPEARED NEGATIVE AS REPORTED BY THE INSTRUMENT. THE CUSTOMERS REPEAT TESTING WAS PERFORMED WITH A NEW POUCH (SAME LOT) OF TEST STRIPS WHEN THE EXPECTED POSITIVE REACTIONS WERE OBTAINED. THE UNEXPECTED NEGATIVE REACTIVITY MAY HAVE BEEN DUE TO STRIPS BEING COMPROMISED DUE TO STORAGE/HANDLING. AN IMMUCOR FIELD SERVICE ENGINEER PERFORMED THE UNEXPECTED REACTION CHECKLIST, CLEANED THE WASHER MANIFOLD, AND REPLACED THE CENTRIFUGE UNIVERSAL COUPLER. QC 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 M00294.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225963 GALILEO ECHO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR