BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2912551 · Received January 13, 2013

    Report

    Report Number
    2050012-2013-00033
    Event Type
    Malfunction
    Date Received
    January 13, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: ION SELECTIVE ELECTRODE DRAIN. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THERE WAS CLOUDY FLUID ON THE FLOOR UNDER THE MODULAR CHEMISTRIES (MC) SECTION OF THE SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM (LX 20). CUSTOMER REPORTED THE DRIP TRAY WAS FULL IN THE MC SIDE OF THE REAGENT COMPARTMENT. CUSTOMER REPORTED THE LX 20 SYSTEM DID NOT GENERATE ANY ERRONEOUS PATIENT RESULTS. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE TO EVALUATE THE INSTRUMENT. THE FSE FOUND FLUID ON THE FLOOR. THE FSE FOUND THE FLUID WAS COMING FROM THE ION SELECTIVE ELECTRODE OVERFLOW DRAIN LINE. THE FSE REPLACED THE ELECTROLYTE INJECTION CUP. THE FSE ALSO PERFORMED MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19465 SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1