BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2589549 · Received May 27, 2012

    Report

    Report Number
    2050012-2012-01182
    Event Type
    Malfunction
    Date Received
    May 27, 2012
    Date of Event
    May 2, 2012
    Report Date
    May 2, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 AN ERRONEOUS CREATININE RESULT. CUSTOMER REPORTED THAT THE ERRONEOUS RESULT WAS NOT 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) REPLACED THE MODULAR CHEMISTRY REAGENT SYRINGE. THE FSE ALSO PERFORMED PREVENTIVE MAINTENANCE.

    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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR