BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX CLINICAL SYSTEM, MODEL LX20

    MDR report key: 2873170 · Received December 13, 2012

    Report

    Report Number
    2050012-2012-01911
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K014034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND EXAMINED THE SYSTEM. THE FSE FOUND THE MODULAR CHEMISTRY OBSTRUCTION TRANSDUCER WAS LEAKING. THE ENGINEER REMOVED AND REPLACED THE LEAKING OBSTRUCTION TRANSDUCER. THE REPAIR WAS VERIFIED AND MET SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER INC. THAT THE MODULAR CHEMISTRY SAMPLE PROBE ON THEIR SYNCHRON LX CLINICAL SYSTEM, MODEL LX20 INSTRUMENT WAS LEAKING. THE CUSTOMER WAS NOT PROCESSING PATIENT SAMPLES AT THE TIME. ACCORDINGLY, NO RESULTS WERE RELEASED FROM THE LABORATORY AND THERE ARE NO REPORTS OF ANY CHANGES TO THE CARE OR TREATMENT OF A PATIENT. THERE ARE NO REPORTS OF ANY INJURIES OR EXPOSURES TO ANY LABORATORY PERSONNEL. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO EVALUATE THE INSTRUMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1