BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2361374 · Received December 7, 2011

    Report

    Report Number
    2050012-2011-08178
    Event Type
    Malfunction
    Date Received
    December 7, 2011
    Date of Event
    November 7, 2011
    Report Date
    November 7, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE UNICEL DXC 800 SYNCHRON SYSTEM GENERATED SUPPRESSED RESULTS FOR BLOOD UREA NITROGEN (BUNM) AND CREATININE (CREM) ON PATIENT SAMPLES. CUSTOMER REPORTED THAT FLUID WAS DRIPPING FROM THE BOTTOM OF THE MODULAR CHEMISTRY (MC) SAMPLE PROBE. CUSTOMER REPORTED THAT QUALITY CONTROL (QC) WAS ALSO SUPPRESSED. CUSTOMER REPORTED THAT THE SUPPRESSED RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND THE MODULAR CHEMISTRY (MC) SAMPLE PROBE WAS DRIPPING DUE TO THE WASTE VALVE CLOGGED WITH GEL. THE FSE CLEANED THE VALVE, PRIMED THE INSTRUMENT, CALIBRATED, AND RAN CONTROLS. THERE WAS NO FURTHER ISSUE NOTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1