BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2183661 · Received July 8, 2011

    Report

    Report Number
    2050012-2011-02918
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    March 24, 2008
    Report Date
    March 24, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    Z-2388-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SVC ENGINEER (FSE) VISITED THE FACILITY AND EXAMINED THE SYS. CULTURES OF THE SYS WERE TAKEN. THE CULTURE RESULTS ARE POSITIVE FOR (B)(6). THE FSE DECONTAMINATED THE SYS AND REPLACED THE ISE (ION SELECTIVE ELECTRODE) MODULE. WHILE THIS MEASURE MAY HAVE RESOLVED THE PROBLEM, A CLEAR ROOT CAUSE 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 ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ERRONEOUS LOW SODIUM RESULTS WERE GENERATED BY THE UNICEL DXC 800 SYNCHRON SYSTEM DUE TO CONTAMINATION. THE RESULTS WERE REPORTED OUT OF THE LAB. THE CUSTOMER RETESTED THE SAMPLES AND OBTAINED RESULTS WITHIN EXPECTATIONS. CORRECTED RESULTS WERE THEN REPORTED. THERE WAS NO CHANGE TO THE PTS' CARE OR TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ISE ELECTROLYTE BUFFER| ISE ELECTROLYTE REFERENCE