BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® I 725 CLINICAL SYSTEM

    MDR report key: 1663127 · Received April 20, 2010

    Report

    Report Number
    2050012-2010-00201
    Event Type
    Malfunction
    Date Received
    April 20, 2010
    Date of Event
    March 24, 2010
    Report Date
    April 20, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CALIBRATION AND QC ARE RUN EVERY 8 HOURS. QC PRIOR TO AND AFTER THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT, BUT FOUND NO PROBLEMS. THE FSE PERFORMED A PRECISION RUN ON NA, WHICH PASSED THE SPECIFICATIONS. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. 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 A FALSE LOW SODIUM (NA) RESULT GENERATED BY THE SYNCHRON LXI 725 CLINICAL SYSTEM. THE ORIGINAL RESULT OF 117 MMOL/L WAS REPORTED OUTSIDE OF THE LAB AND WAS QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS RUN ON ANOTHER INSTRUMENT AND THE RESULT OBTAINED WAS 138 MMOL/L. THE ORIGINAL RESULT WAS AMENDED. IT IS UNKNOWN IF TREATMENT WAS INITIATED OR WITHHELD BASED UPON THE FALSE LOW RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1