BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 3951113 · Received July 22, 2014

    Report

    Report Number
    1034569-2014-00129
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 25, 2014
    Report Date
    July 22, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD TO ASSESS THE TEST WELL IMAGES ON THE TESTING INSTRUMENT ON (B)(4) 2014. AN IMMUCOR FIELD SERVICE ENGINEER VISITED CUSTOMER SITE TO ASSESS INSTRUMENT ON (B)(4) 2014. EXTENSIVE TROUBLESHOOTING WAS PERFORMED AND THE INSTRUMENT THEN SUBSEQUENTLY PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A CUSTOMER REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN TESTING A BLOOD SAMPLE ON A GALILEO ECHO ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427961 GALILEO ECHO AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1