BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2172302 · Received June 24, 2011

    Report

    Report Number
    2050012-2011-02483
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    August 1, 2010
    Report Date
    August 6, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    Z-2388-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) VISITED THE FACILITY AND EXAMINED THE SYSTEM. THE FSE NOTICED THAT THE GLUCOSE MODULE COVER WAS NOT PROPERLY SECURED FOLLOWING CUSTOMER INITIATED MAINTENANCE. FAILURE TO PROPERLY REPLACE THE GLUCOSE MODULE COVER CAUSES THE SAMPLE PROBE TO CONTACT THE MODULE COVER RESTRICTING ITS MOVEMENT THUS CAUSING A SHORT SAMPLE SCENARIO. THIS IS ONE OF FOUR MEDWATCH REPORTS BEING SUBMITTED AS FOUR SEPARATE EVENTS WERE RECORDED ON DIFFERENT DAYS. REFERENCE THE MDR NUMBERS BELOW FOR ALL ASSOCIATED REPORTS: 2050012-2010-00624, 2050012-2011-02484, 2050012-2011-02485. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ERRONEOUSLY GLUCOSE RESULTS WERE GENERATED BY THE UNICEL DXC 800 SYNCHRON SYSTEM FROM SAMPLES THAT ARE RUN IN DUPLICATE. THE INITIAL RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER RE-TESTED THE SAMPLE IN DUPLICATE AND OBTAINED CONSISTENT RESULTS THAT WERE WITHIN EXPECTATIONS. THERE WAS NO CHANGE TO THE PATIENTS' CARE OR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 800 SYNCHRON SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK