BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2172276 · Received June 24, 2011

    Report

    Report Number
    2050012-2011-02482
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    October 29, 2008
    Report Date
    October 29, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) VISITED THE FACILITY AND REPLACED THE GLUCOSE STIRRER MOTOR. A SPECIFIC ROOT CAUSE OF THIS SINGLE EVENT HAS NOT BEEN IDENTIFIED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(6), 2008 AND (B)(6), 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT ERRONEOUSLY LOW GLUCOSE RESULTS WERE GENERATED BY THE UNICEL DXC 800 SYNCHRON SYSTEM. THE SYSTEM GENERATED CRITICAL RE-RUN FEATURE WAS TRIGGERED AND RETURNED A RESULT WITHIN EXPECTATIONS. THE SAMPLE WAS RE-TESTED ON ANOTHER DXC SYSTEM AND RETURNED A RESULT WITHIN EXPECTATIONS. IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO THE PATIENTS' CARE OR TREATMENT; HOWEVER, THE INITIAL RESULTS WERE NOT REPORTED OUT OF THE LABORATORY.

    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