BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2476561 · Received March 5, 2012

    Report

    Report Number
    2050012-2012-00629
    Event Type
    Malfunction
    Date Received
    March 5, 2012
    Date of Event
    February 7, 2012
    Report Date
    February 9, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K011213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: CARBON BRIDGE, FLOWCELL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM (LX20) GENERATED HIGH SODIUM (NA) RESULTS. CUSTOMER REPORTED THAT THREE DIFFERENT DOCTORS QUESTIONED THE HIGH RESULTS. CUSTOMER REPORTED THAT THE SAMPLES WERE RE-RAN ON THE LX 20 AND THE OTHER LX 20 IN THE LABORATORY AFTER THE DOCTORS QUESTIONED THE RESULTS. CUSTOMER REPORTED THAT THE OTHER LX 20 IN THE LABORATORY GAVE NORMAL RESULTS. CUSTOMER REPORTED THAT ONLY NA RESULTS >145 MMOL/L WERE AFFECTED. THE NA RESULTS IN THE LOWER RANGES WERE ACCEPTABLE. CUSTOMER REPORTED THAT QUALITY CONTROL (QC) EXCEEDED LAB-ESTABLISHED RANGES ONCE ON THE DAY OF THE EVENT, BUT THE OPERATOR IGNORED THE OUT OF RANGE QC. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) NOTICED BLUE GROWTH IN THE FLOWCELL. THE FSE DECONTAMINATED THE FLOWCELL. THE FSE REPLACED THE CARBON BRIDGE AND LINE #23. THE FSE VERIFIED PERFORMANCE OF THE LX 20.

    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 JGS BECKMAN COULTER, INC. LX 20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1