BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2153107 · Received June 17, 2011

    Report

    Report Number
    2050012-2011-02391
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    October 7, 2009
    Report Date
    October 7, 2009
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE FACILITY. THE SYSTEM WAS EXAMINED. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE GLUCOSE MODULE AT THE CUSTOMERS' REQUEST. UPON FURTHER INVESTIGATION, THE FSE DETERMINED THAT THE ROOT CAUSE IS RELATED TO A SAMPLE SPECIFIC AND SHORT SAMPLE SITUATION. THE LAB HAS PREANALYTICAL SAMPLE PROCESSING ISSUES RELATED TO ON-GOING LAB TRAINING ISSUES. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AN ERRONEOUSLY LOW GLUCOSE CUP RESULT WAS GENERATED BY THE UNICEL DXC 600 SYNCHRON SYSTEM. QUALITY CONTROLS WERE WITHIN SPEC PRIOR TO AND AFTER THE EVENT. THE SYSTEM GENERATED CRITICAL RE-RUN FEATURE WAS TRIGGERED AND YIELDED RESULTS WITHIN THE EXPECTED RANGE. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LAB; THE CRITICAL RE-RUN RESULT WAS REPORTED. THERE WAS NO CHANGE TO THE PTS' TREATMENT OR CARE AS A RESULT OF THIS EVENT SINCE THE INITIAL RESULTS WERE NOT REPORTED OUT OF THE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600 SYNCHRON SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR