BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS

    MDR report key: 1100204 · Received July 30, 2008

    Report

    Report Number
    2050012-2008-00033
    Event Type
    Other
    Date Received
    July 30, 2008
    Date of Event
    July 4, 2008
    Report Date
    July 30, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    NO OTHER ANALYTES RUN WITH THE FOUR SAMPLES WERE QUESTIONED BY PHYSICIANS. INSTRUMENT STARTED GIVING SUPPRESSED RESULTS AND REACTION NOISE ERRORS PRIOR TO ERRONEOUS RESULTS. THEN FALSE LOW RESULTS WERE NOTICED BY LAB BECAUSE THEY FAILED DELTA CHECKS. LAB CLEANED MODULE, FLUSHED TUBING AND PERFORMED A LAMP CALIBRATION. PER CUSTOMER, QUALITY CONTROL WAS RUN EVERY HOUR AND HAD NO ISSUES. CALIBRATION WAS ACCEPTABLE PRIOR TO RUNNING THESE SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE: FSE REPLACED THE CREATININE MODULE STIRRER MOTOR. PER CUSTOMER IN 2008, CREATININE HAS BEEN RUNNING FINE SINCE THEN. BCI REP HAS REQUESTED THE MOTOR BE RETURNED TO BREA. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FOUR ERRONEOUSLY LOW CREATININE (CRE) TEST RESULTS PRODUCED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. ONLY ONE EXAMPLE OF THE ERRONEOUS RESULTS WAS PROVIDED. THE ORIGINAL RESULT WAS 46UMOL/L AND THE CORRECTED RESULT WAS 95UMOL/L. UNKNOWN IF TREATMENT WAS INITIATED OR WITHHELD BUT RESULTS WERE QUESTIONED BY THE PHYSICIANS. PER CUSTOMER, NO INCIDENT REPORT WAS FILED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA