BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2180970 · Received July 1, 2011

    Report

    Report Number
    2050012-2011-02756
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    February 26, 2010
    Report Date
    March 3, 2010
    Manufacturer
    BECKMAN COULTER, INC
    Product Code
    CGA
    PMA / PMN Number
    K042291
    Removal / Correction Number
    Z-2388-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) VISITED THE FACILITY AND EXAMINED THE SYSTEM. THE FSE NOTED THAT THE SAMPLE WHEEL COVER WAS NOT PROPERLY PLACED ON THE SYSTEM. THE SAMPLE WHEEL COVER WAS PROPERLY SEATED. THE CUSTOMER WAS PREVIOUSLY ALERTED TO THIS SCENARIO. THE ROOT CAUSE OF THIS EVENT APPEARS TO BE SAMPLE WHEEL COVER MISALIGNMENT CONTRIBUTING TO IMPROPER MODULAR CHEMISTRY PROBE HEIGHT CLEARANCE. THIS IS ONE OF NINE MEDWATCH REPORTS BEING SUBMITTED AS THE CUSTOMER PROVIDED DATA FOR NINE INDIVIDUAL PT EVENTS. REFERENCE THE MDR NUMBERS BELOW FOR ALL ASSOCIATED EVENTS: MDR# 2050012-2011-02687, 02750, 02751, 02752, 02753, 02754, 02755, 02757. 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 ERRONEOUSLY LOW GLUCOSE RESULTS WERE GENERATED BY THE UNICEL DXC 600 SYNCHRON SYSTEM. THE SYSTEM GENERATED CRITICAL RERUN FEATURE WAS TRIGGERED AND ALSO GENERATED A LOW RESULT. THE INITIAL RESULT WAS REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS RETESTED ANOTHER DXC SYSTEM AND YIELDED A RESULT WITHIN EXPECTATIONS. AMENDED RESULTS WERE REPORTED. QUALITY CONTROLS WERE WITHIN SPECIFICATION PRIOR TO AND AFTER THE EVENT. IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO THE PT'S CARE OR TREATMENT. THERE IS NO REPORT OF ANY SERIOUS INJURY OR NEED FOR MEDICAL INTERVENTION TO PREVENT OR PRECLUDE SERIOUS INJURY RELATED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR