BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® I 725 CLINICAL SYSTEM

    MDR report key: 1972057 · Received January 27, 2011

    Report

    Report Number
    2050012-2011-00201
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    December 31, 2010
    Report Date
    December 31, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    URINE SODIUM QC WAS OUT HIGH AND CUSTOMER STOPPED RUNNING SAMPLES. WHEN QC WAS RUN AFTER THE EVENT IT WAS OUT OF RANGE HIGH FOR LEVEL I, AND ON UPPER END OF RANGE FOR LEVELS II AND III. HOTLINE HAD THE CUSTOMER PERFORM ROUTINE MAINTENANCE. CUSTOMER DECLINED SERVICE AT THIS TIME. ON (B)(4) 2011, THE CUSTOMER CALLED BACK AND REQUESTED SERVICE. SERVICE IDENTIFIED BUBBLES IN THE RATIO PUMP. SERVICE REPLACED THE PISTON, REBUILT THE PUMP AND VERIFIED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A FALSE HIGH SODIUM (NA) RESULT OF 160MMOL/L GENERATED BY THE SYNCHRON LX I 725 CLINICAL SYSTEM FOR ONE SAMPLE. THE SPECIMEN WAS REPEATED ON A DIFFERENT INSTRUMENT, GIVING A RESULT OF 144MMOL/L, WHICH WAS REPORTED OUT OF THE LAB. NO FALSE HIGH RESULT WAS REPORTED OUT OF THE LAB. PATIENT TREATMENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX® I 725 CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1