BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2880679 · Received December 20, 2012

    Report

    Report Number
    2050012-2012-01914
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND EXAMINED THE SYSTEM. THE ENGINEER CLEANED THE FLOWCELL, ELECTROLYTE INJECTOR CUP AND THE SAMPLE PROBE. THE FSE THEN REMOVED AND REPLACED THE WASH COLLAR AND BOTH SODIUM ELECTRODES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER THAT FALSE LOW SODIUM (NA) RESULTS FOR APPROXIMATELY 22 PATIENT SAMPLES WERE GENERATED BY THE UNICEL DXC 800 SYNCHRON SYSTEM. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED ON ANOTHER INSTRUMENT WHEN THE ISSUE WAS NOTED AND AMENDED RESULTS WERE ISSUED. THERE ARE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND THERE ARE NO REPORTS OF ANY CHANGES TO THE PATIENTS CARE OR TREATMENT. THE CUSTOMER PROVIDED ONLY ONE EXAMPLE OF FALSE RESULTS. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1