BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS

    MDR report key: 1690146 · Received May 14, 2010

    Report

    Report Number
    2050012-2010-00258
    Event Type
    Malfunction
    Date Received
    May 14, 2010
    Date of Event
    April 26, 2010
    Report Date
    May 14, 2010
    Manufacturer
    BECKMAN COULTER INC
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISE SYSTEM IS ROUTINELY CALIBRATED EVERY 24 HOURS. QC SAMPLES ARE RUN EVERY 8 HOURS. THE BCI ENGINEER DECONTAMINATED THE ISE SYSTEM. MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS ANALYSIS.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) IN REGARDS TO ERRONEOUSLY HIGH SODIUM (NA) AND POTASSIUM (K) RESULTS, WHICH WERE GENERATED BY UNICEL DXC 600 PRO CHEMISTRY ANALYZER. THE CUSTOMER SUPPLIED ONE EXAMPLE OF A FALSE HIGH NA RESULT WHICH 174 MMOL/L ON RUN ONE AND 136 MMOL/L ON REPEAT RUN. SODIUM RESULTS WERE NOT REPORTED OUT OF LABORATORY AND PATIENT TREATMENT WAS NOT IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JGS BECKMAN COULTER INC UNICEL DXC 600 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1