BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2183594 · Received July 8, 2011

    Report

    Report Number
    2050012-2011-02907
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    May 4, 2008
    Report Date
    May 4, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    Z-0863-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SVC ENGINEER (FSE) VISITED THE FACILITY AND EXAMINED THE SYS. THE FSE DECONTAMINATED THE SYS. 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 01/01/2008 AND 10/23/2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ERRONEOUSLY LOW SODIUM RESULTS WERE GENERATED BY THE UNICEL DXC 800 SYNCHRON SYS. IT IS NOT KNOWN IF THE RESULTS WERE REPORTED OUT OF THE LAB. THE CUSTOMER NOTED A GREENISH RESIDUE IN THE FLOW CELL. THE CUSTOMER IS NOT FAMILIAR WITH MAINTENANCE PROCEDURES AND REPORTEDLY DID NOT WISH TO PERFORM WEEKLY MAINTENANCE TO RID THE SYS OF THE GREENISH RESIDUE. THERE WAS NO REPORT OF ANY CHANGE TO THE PTS' CARE OR TREATMENT. THERE IS NO REPORT OF ANY ADVERSE EVENT OR SERIOUS INJURY. THE CUSTOMER RUNS QUALITY CONTROLS EVERY HOUR AND CALIBRATES THE SYS AS NECESSARY TO BRING THE QUALITY CONTROLS WITHIN RANGE.

    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 REFERENCE| ISE ELECTROLYTE BUFFER