BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 1961960 · Received January 15, 2011

    Report

    Report Number
    2050012-2011-00163
    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
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT NO INCORRECT POTASSIUM RESULTS WERE GENERATED DUE TO REFERENCE DRIFT ERRORS. A BCI FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM AND INDICATED THE SYSTEM WAS UP TO DATE ON MODIFICATION AND MAINTENANCE. THE FSE FOUND THE SAMPLE PROBE WAS OUT OF ALIGNMENT. THE FSE REPLACED THE POTASSIUM TIP AS A PRECAUTION. THE FSE RAN A PRECISION RUN ON ALL ISE (ION SELECTIVE ELECTRODES) CHEMISTRIES AND ALL THE RESULTS WERE ACCEPTABLE. THE FSE ALSO CHECKED CALIBRATIONS.

    Description of Event or Problem · 1

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

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1