BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2891114 · Received December 31, 2012

    Report

    Report Number
    2050012-2012-01945
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 6, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND EXAMINED THE SYSTEM. THE FSE FOUND A LOOSE AND POTENTIALLY OBSTRUCTED SAMPLE PROBE. THE FSE ALSO FOUND THE ELECTROLYTE INJECTOR CUP VALVE WAS NOT PROPERLY FUNCTIONING CAUSING SLUGGISH DRAINAGE. THE FSE REMOVED AND REPLACED THE PROBE AND VALVE. A SPECIFIC FAILURE MODE WAS NOT IDENTIFIED. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER INC. THAT FALSE LOW SODIUM (NA) RESULTS WERE GENERATED BY THE UNICEL DXC 800 SYNCHRON SYSTEM FOR 2 PATIENT SAMPLES. THE RESULTS WERE REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE ATTENDING PHYSICIAN. THE SAMPLES WERE RETESTED AND AMENDED RESULTS ISSUED. QUALITY CONTROLS WERE LOW PRIOR TO THE EVENT BUT WITHIN THE LABORATORY'S ESTABLISHED RANGES. THERE ARE NO REPORTS OF ANY CHANGES TO THE PATIENTS' CARE OR TREATMENT. 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