BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO

    MDR report key: 1062623 · Received June 23, 2008

    Report

    Report Number
    1034569-2008-00201
    Event Type
    Malfunction
    Date Received
    June 23, 2008
    Date of Event
    May 27, 2008
    Report Date
    June 19, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A LIMITATION OF THE ECHO, ACCORDING THE OPERATOR MANUAL, IS THAT HEMAGGLUTINATION REACTIONS GRADED 1+ OR LESS IN TUBE, MAY NOT BE DETECTED ON THE ECHO.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNEXPECTED NEGATIVE REACTION WITH ANTI-D SERIES 5 ON A PATIENT SAMPLE RUN ON THE ECHO. CUSTOMER HAD RUN THE SAMPLE IN TUBE USING ANTI-D MONOCLONAL BLEND AND HAD POSITIVE (3+) REACTIONS.

    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 18 YR