BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX I 725 CLINICAL SYSTEM

    MDR report key: 2555413 · Received May 1, 2012

    Report

    Report Number
    2050012-2012-01006
    Event Type
    Malfunction
    Date Received
    May 1, 2012
    Date of Event
    April 6, 2012
    Report Date
    April 6, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE SYNCHRON LXI 725 CLINICAL SYSTEM WAS GIVING ERRONEOUS PATIENT RESULTS ON MODULAR CREATININE. CUSTOMER REPORTED THAT THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. CUSTOMER REPORTED THAT THE ERRONEOUS RESULTS WERE AMENDED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND THAT THE STIRRER MOTOR WAS NOT OPERATING PROPERLY. THE FSE REPLACED THE CREATININE MODULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX I 725 CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR