BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO

    MDR report key: 1222625 · Received November 10, 2008

    Report

    Report Number
    1034569-2008-00536
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    October 13, 2008
    Report Date
    November 4, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAMERA WAS CHANGED ON THE ECHO; HOWEVER, THE PROBLEM PERSISTED. THE INSTRUMENT WAS REPLACED, AND THE NEW INSTRUMENT FUNCTIONS AS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A PATIENT SAMPLE HAD A POSITIVE ANTIBODY SCREEN ON GALILEO, AND NEGATIVE ANTIBODY SCREEN ON ECHO.

    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