BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2153105 · Received June 17, 2011

    Report

    Report Number
    2050012-2011-02304
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    March 1, 2009
    Report Date
    March 20, 2009
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) VISITED THE FACILITY AND EXAMINED THE SYSTEM. A DAMAGED GLUCOSE ELECTRODE WAS FOUND. THE FSE REPLACED THE GLUCOSE ELECTRODE; THE ISSUE WAS NOT RESOLVED. ACCORDINGLY, THE FSE THEN REPLACED THE GLUCOSE MODULE REAGENT PUMP. THE SYSTEM WAS FUNCTIONING WITHIN SPEC. ALTHOUGH, SEVERAL PARTS WERE REPLACED, THE SPECIFIC ROOT CAUSE OF THIS EVENT COULD NOT BE IDENTIFIED. 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 800 SYNCHRON SYSTEM. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. THE SAMPLES WERE REPEATED AND THE RESULTS OBTAINED WERE WITHIN EXPECTATION. THERE WAS NO DEATH, INJURY OR CHANGE TO THE PTS' CARE OR TREATMENT. THE SPECIFIC NUMBER OF PT SAMPLES INVOLVED IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 800 SYNCHRON SYSTEM CGA BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK