BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON CLINICAL SYSTEM

    MDR report key: 1961961 · Received January 15, 2011

    Report

    Report Number
    2050012-2011-00164
    Event Type
    Malfunction
    Date Received
    January 15, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM AND INDICATED THE SYSTEM WAS UP TO DATE ON MODIFICATION AND MAINTENANCE. THE FSE COULD NOT FIND ANY ISE (ION SELECTIVE ELECTRODES) MODULE PROBLEMS. NO REPAIR WAS PERFORMED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS SODIUM (NA) AND CHLORIDE (CL) RESULTS GENERATED BY UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM FOR ONE PATIENT. THE RESULTS WERE REPORTED OUT OF THE LABORATORY.REPEAT TESTING PRODUCED HIGHER RESULTS. NO EFFECT TO THE PATIENT WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1