BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO

    MDR report key: 1031641 · Received April 22, 2008

    Report

    Report Number
    1034569-2008-00112
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 14, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS INFORMED THAT THE CROSSMATCH PERFORMED ON THE ECHO IS A IGG CROSSMATCH. THE OPERATOR MANUAL STATES IN THE LIMITATIONS SECTION, THAT "THE RED BLOOD CELL CROSSMATCH (IGG) IS INTENDED ONLY FOR THE DETECTION OF INCOMPATIBILITIES DUE TO IGG ANTIBODIES. THE RED BLOOD CELL CROSSMATCH (IGG) IS NOT INTENDED FOR THE DETECTION OF INCOMPATIBILITIES DUE TO IGM ANTIBODIES, SUCH AS ABO INCOMPATIBILITIES."

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WHEN CROSSMATCHING A GROUP O PATIENT SAMPLE WITH GROUP A DONOR WHEN PERFORMING CROSSMATCHES ON THE ECHO. THE PATIENT SAMPLE, WHICH IS GROUP A2, WAS REPORTED AS GROUP O ON THE ECHO. WHEN CROSSMATCHED WITH A GROUP A DONOR, RESULTS WERE COMPATIBLE. NO ADVERSE REACTIONS OR TRANSFUSIONS OCCURRED AS A RESULT OF THE UNEXPECTED NEGATIVE REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC. M00147

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR