BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX I 725 CLINICAL SYSTEM

    MDR report key: 2778894 · Received October 9, 2012

    Report

    Report Number
    2050012-2012-01516
    Event Type
    Malfunction
    Date Received
    October 9, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 14, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CFR
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE SYNCHRON LXI 725 CLINICAL SYSTEM GENERATED ERRONEOUS GLUCOSE RESULTS. CUSTOMER REPORTED THAT THE ERRONEOUS RESULTS WERE 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 CHEMISTRIES (MC) SAMPLE PROBE, THE MC SAMPLE SYRINGE AND THE MC COLLAR WASH.

    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 CFR BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1