BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER

    MDR report key: 1344209 · Received February 2, 2009

    Report

    Report Number
    2050012-2009-00007
    Event Type
    Other
    Date Received
    February 2, 2009
    Date of Event
    January 16, 2009
    Report Date
    February 2, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MZV
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE DRAWN IN SST'S OR PST'S. QC IS ROUTINELY RUN EVERY 8 HOURS. PRIOR TO THE EVENT QC RESULTS WERE WITHIN THE ESTABLISHED LIMITS. A FIELD SERVICE ENGINEER (FSE) VISITED THE LAB ON (B)(6) 2009 AND DECONTAMINATED THE FLOW CELL AND REPLACED ALL ELECTRODES OR ELECTRODE TIPS. AS OF (B)(6) 2009 THERE WERE NO FURTHER OCCURRENCES OF HIGH K RESULTS. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE OF THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGRADING ERRONEOUSLY HIGH POTASSIUM (K) RESULTS PRODUCED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. CUSTOMER REPORTED THAT INTERMITTENTLY HIGH K RESULTS HAVE BEEN PRODUCED BY THE ANALYZER AFTER THE SYSTEM HAS BEEN IDLE. THE HIGH RESULTS OCCURED ON THE FIRST FEW SAMPLES RUN WHEN STARTING FROM STANDBY. ONLY ONE EXAMPLE OF THE RESULTS WERE PROVIDED. SAMPLE WAS REPORTED WITH A K RESULT OF 5.5 MMOL/L. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN'S STAFF. WHEN REPEATED THE RESULT WAS 4.6 MMOL/L AND THE ORIGINAL RESULT WAS AMENDED. THE CUSTOMER HAS NOT RECEIVED ANY REPORT OF PT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA