BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2494755 · Received March 16, 2012

    Report

    Report Number
    2050012-2012-00672
    Event Type
    Malfunction
    Date Received
    March 16, 2012
    Date of Event
    February 18, 2012
    Report Date
    February 20, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES - RESULTS CODE - (OTHER): WIPER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM (LX 20) GAVE MIXER SPEED ERRORS AND THE MIXER BROKE. CUSTOMER REPORTED THAT THE LX 20 GENERATED ERRONEOUS RESULTS. CUSTOMER REPORTED THAT NINE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. CUSTOMER REPORTED THAT TWO 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 THE WIPER FOR THE WASH STATION WAS NOT PRESENT. THE FSE FOUND THE WIPER WAS STUCK IN ONE OF THE CUVETTES. THE FSE REPLACED THE MIXER AND THE WIPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. LX 20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1