BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2172278 · Received June 24, 2011

    Report

    Report Number
    2050012-2011-02412
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    December 1, 2009
    Report Date
    December 1, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) EXAMINED THE SYSTEM. THE FSE INSTALLED A NEW GLUCOSE ELECTRODE AND REAGENT SYRINGE. ALTHOUGH MULTIPLE PARTS WERE REPLACED, THE SPECIFIC ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. 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 GLUCOSE RESULT WAS GENERATED BY THE UNICEL DXC 800 SYNCHRON SYSTEM. THE SYSTEM GENERATED CRITICAL RE-RUN FEATURE WAS TRIGGERED AND THE RESULT WAS WITHIN EXPECTATIONS. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS ALSO RE-RUN ON ANOTHER SYSTEM AND YIELDED A RESULT 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