BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2153149 · Received June 17, 2011

    Report

    Report Number
    2050012-2011-02392
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    September 28, 2009
    Report Date
    September 28, 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
    HI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND EXAMINED THE SYSTEM. THE FSE REPLACED THE GLUCOSE MODULE. ALTHOUGH, PARTS WERE REPLACED, A SPECIFIC ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED. 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 800 SYNCHRON SYSTEM. THE RESULT TRIGGERED THE SYSTEM GENERATED CRITICAL RE-RUN FEATURE. THE RE-RUN RESULT WAS WITHIN EXPECTATIONS. THE RE-RUN RESULT WAS REPORTED OUT OF THE LAB. THERE WAS NO DEATH, INJURY OR CHANGE TO THE PT'S CARE OR TREATMENT RELATED TO THIS EVENT.

    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