BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO

    MDR report key: 1220004 · Received November 6, 2008

    Report

    Report Number
    1034569-2008-00532
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 9, 2008
    Report Date
    November 3, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONFIRMED THE TEST RESULT AS O POSITIVE UPON REPEAT TESTING. REVIEW OF THE RESULT FILES FROM THE DEVICE SHOWS A WELL SCORE OF 20 IN WELL 3, ANTI-B WELL, RESULTING IN A 1+ REACTION. REVIEW OF WELL IMAGE SHOWS A LINE OF RED COLORED ARTIFACT (HAIR?) PRESENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED POSITIVE REACTIONS(1+) WITH ANTI-B ON ECHO WHEN RUNNING A CONFIRMATION TEST FOR A KNOWN GROUP O DONOR UNIT. THE DONOR UNIT RESULTED AS GROUP B INSTEAD OF GROUP O.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1