BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2372341 · Received December 14, 2011

    Report

    Report Number
    2050012-2011-08425
    Event Type
    Malfunction
    Date Received
    December 14, 2011
    Date of Event
    November 16, 2011
    Report Date
    November 16, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT WASTE STARTED TO LEAK OUT OF THE MODULAR CHEMISTRY (MC) DRAIN RELIEF LINE OF THE SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM (LX 20) AND SPILLED TO THE FLOOR. CUSTOMER REPORTED THAT THEY PERFORMED A SHUTDOWN AND REBOOTED. CUSTOMER REPORTED THAT THE LX 20 IS NO LONGER LEAKING AFTER THE REBOOT. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.

    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