BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 2841352 · Received November 21, 2012

    Report

    Report Number
    1034569-2012-00216
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 16, 2012
    Report Date
    November 21, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE IMAGE FILES SHOWED THAT REACTIONS APPEARED AS EXPECTED. UPON REPEAT TESTING, A DIFFERENT VIAL (SAME LOT) OF LISS WAS USED THAN WAS USED FOR INITIAL TESTING, THE EXPECTED RESULTS WERE OBTAINED. THE INSTRUMENT IS OPERATING AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT AN UNEXPECTED NEGATIVE REACTION WAS OBTAINED ON THE 3-CELL SCREENING ASSAY ON GALILEO ECHO (B)(4) WITH A KNOWN ANTI-E SAMPLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR