BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2183545 · Received July 8, 2011

    Report

    Report Number
    2050012-2011-02829
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    December 30, 2009
    Report Date
    December 30, 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
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE CALL FOR SYS EVAL WAS DECLINED BY THE CUSTOMER. THE CUSTOMER PROVIDED PT DATA AND QUALITY CONTROL INFO. THE QUALITY CONTROLS BEFORE AND AFTER THE EVENT WERE WITHIN SPEC. W/O A FULL EXAMINATION OF THE SYS (WHICH WAS DECLINED BY THE CUSTOMER), A SPECIFIC ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED; ACCORDINGLY, NO CONCLUSION CAN BE DRAWN. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AN ERRONEOUSLY LOW CRITICAL RERUN GLUCOSE RESULT WAS GENERATED BY THE UNICEL DXC 800 SYNCHRON SYSTEM AFTER THE INITIAL TEST YIELDED A RESULT BELOW THE LAB'S REFERENCE RANGE. THE RESULT WAS NOT REPORTED OUTSIDE THE LAB. THE CUSTOMER RETESTED THE SAMPLE MULTIPLE TIMES ON A DIFFERENT SYS AND THE RESULTS MATCHED THE INITIAL RESULT. THE AMENDED RESULT WAS REPORTED. THERE WAS NO CHANGE TO THE PT'S CARE OR TREATMENT. THE CUSTOMER OPINES THIS EVENT WAS SAMPLE SPECIFIC.

    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 61 YR LX GLUCOSE 2X2L