BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2689768 · Received August 9, 2012

    Report

    Report Number
    2050012-2012-01660
    Event Type
    Malfunction
    Date Received
    August 9, 2012
    Date of Event
    July 22, 2012
    Report Date
    July 22, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE MODULAR CHEMISTRY DRIP TRAY ON SYNCHRON LX20 PRO CLINICAL CHEMISTRY SYSTEM WAS FULL WITH FLUID, WHICH LEAKED ONTO THE FLOOR. THE ELECTROLYTES FAILED CALIBRATIONS, AND NO ERRONEOUS PATIENT RESULTS WERE GENERATED. THE CUSTOMER DID NOT HAVE DIRECT CONTACT WITH THE LEAKED FLUID. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION, AND NO INJURY WAS REPORTED. THE LEAKED FLUID MAY HAVE CONTAINED DILUTED ISE DRAIN FLUIDS, ISE REFERENCE, ISE BUFFER, CALIBRATORS AND CONTROLS. MSDS WAS NOT REVIEWED AND IT IS UNKNOWN IF THE FACILITY HAS A RISK MANAGEMENT PLAN. A FIELD SERVICE ENGINEER (FSE) VISITED THE SITE ON (B)(4) 2012, AND IDENTIFIED AN OCCLUDED DRAIN VALVE. THE FSE DISASSEMBLED THE VALVE, CLEARED THE OCCLUSION AND REASSEMBLED THE UNIT. THE ENGINEER ALSO REPLACED THE MODULAR CHEMISTRY SAMPLE PROBE DUE TO AN OCCLUSION. THE CAUSE OF THE EVENT WAS OCCLUDED DRAIN VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX20 PRO CLINICAL CHEMISTRY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. LX20 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1