BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2411585 · Received January 11, 2012

    Report

    Report Number
    2050012-2012-00018
    Event Type
    Malfunction
    Date Received
    January 11, 2012
    Date of Event
    December 14, 2011
    Report Date
    December 14, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 THE SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM (LX 20) GENERATED NUMEROUS RACK OUT OF RANGE ERRORS, CAUSING THE INSTRUMENT TO STOP. CUSTOMER REPORTED THAT THE LX 20 GENERATED BUNM RXN NOISE (BLOOD UREA NITROGEN REACTION NOISE) ERRORS. CUSTOMER REPORTED THAT THE LX 20 WAS LEAKING AN UNKNOWN FLUID FROM AN UNKNOWN AREA OF THE INSTRUMENT. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) EVALUATED THE LX 20 AND DID NOT NOTICE ANY LEAKING. THE FSE EVALUATE THE LX 20 AND DID NOT OBSERVE RACK OUT OF RANGE ERRORS. THE FSE REPLACED THE BUN ELECTRODE CAPLOCK. THE FSE PERFORMED BUN CALIBRATION. THE FSE VERIFIED THE REPAIR WAS PERFORMED PER ESTABLISHED PROCEDURES. ROOT CAUSE IS UNKNOWN. CUSTOMER REPORTED THAT IT MAY HAVE BEEN RELATED TO USER ERROR.

    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