BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2436637 · Received February 2, 2012

    Report

    Report Number
    2050012-2012-00266
    Event Type
    Malfunction
    Date Received
    February 2, 2012
    Date of Event
    January 8, 2012
    Report Date
    January 8, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM (LX 20 SERIAL NUMBER (B)(4)) GENERATED ERRONEOUS CARBON DIOXIDE (CO2) RESULTS. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. CUSTOMER REPORTED THAT WHEN ANION GAPS ALERTED THE ISSUE, THE SAMPLES WERE RUN ON THE OTHER LX 20 (SERIAL NUMBER (B)(4)). CUSTOMER REPORTED THAT THE SAMPLES RAN ON THE OTHER LX 20 (SERIAL NUMBER (B)(4)) WERE REPORTED OUT OF THE LABORATORY. BEC FIELD SERVICE ENGINEER (FSE) FOUND THAT THE CO2 ACID PORT WAS OBSTRUCTED. THE FSE FLUSHED THE PORT AND CLEANED THE ELECTRODES. THE FSE VERIFIED PERFORMANCE.

    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 34 YR