BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2880688 · Received December 20, 2012

    Report

    Report Number
    2050012-2012-01931
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CFR
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 REPLACED THE GLUCOSE MODULE, GLUCOSE REAGENT AND STRAW, AND THE MODULAR CHEMISTRY SAMPLE PROBE TUBING. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER INC. THAT THE UNICEL DXC 800 SYNCHRON SYSTEM GENERATED ONE (1) FALSE HIGH MODULAR GLUCOSE (GLUM) RESULT. THE RESULT WAS REPORTED OUT OF THE LABORATORY. THE CUSTOMER PERFORMED A PRECISION RUN ON WHICH YIELDED UNACCEPTABLE RECOVERY; ACCORDINGLY, THE CUSTOMER REPEATED THE SAMPLE. AN AMENDED REPORT WAS ISSUED. THERE WERE NO CHANGES TO THE PATIENTS' CARE OR TREATMENT. THE CUSTOMER ADVISED THAT THE QUALITY CONTROL RUN AFTER THE EVENT WAS NOT ACCEPTABLE. A 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 CFR BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1