BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2874560 · Received December 15, 2012

    Report

    Report Number
    2050012-2012-01909
    Event Type
    Malfunction
    Date Received
    December 15, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CFR
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. THAT THE UNICEL DXC 800 SYNCHRON SYSTEM GENERATED ERRONEOUS GLUCOSE RESULTS FOR TEN PATIENT SAMPLES. CUSTOMER REPORTED ONE OF THE ERRONEOUS RESULTS WAS REPORTED OUT OF 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 GLUCOSE SYRINGE WAS NOT FULLY SEATED IN THE PUMP. THE FSE ADJUSTED THE CUP TEMPERATURE FROM 35 DEGREES C TO 37 DEGREES C. THE FSE ALSO REPLACED THE MODULAR CHEMISTRIES SAMPLE PROBE AND CLEANED THE CUP. DUE TO THE INTERMITTENT IMPRECISION ISSUE EXPERIENCED BY THE CUSTOMER, THE FSE REPLACED THE ENTIRE GLUCOSE MODULE AND RELATED TUBING AS A PREVENTIVE MEASURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1