BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2211521 · Received August 5, 2011

    Report

    Report Number
    2050012-2011-03996
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 13, 2008
    Report Date
    July 31, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) VISITED THE FACILITY AND EXAMINED THE SYSTEM. CULTURES OF THE SYSTEM WERE NOT TAKEN OR PROVIDED. THE FSE DECONTAMINATED THE SYSTEM AND REPLACED SEVERAL PARTS. ALTHOUGH SEVERAL PARTS WERE REPLACED AND 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 JANUARY 1, 2008 AND OCTOBER 23, 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ERRONEOUSLY LOW SODIUM RESULTS WERE GENERATED BY THE UNICEL DXC 600 SYNCHRON SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. CALIBRATION AND QUALITY CONTROLS WERE WITHIN SPECIFICATION PRIOR TO THE EVENT. THE SAMPLES WERE RETESTED ON THE FACILITY'S BACK-UP SYSTEM AND YIELDED RESULTS WITHIN EXPECTATIONS. AMENDED RESULTS WERE ISSUED. THERE ARE NO REPORTS OF ANY ADVERSE EVENTS OR NEED FOR MEDICAL INTERVENTION TO PREVENT OR PRECLUDE SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600 SYNCHRON SYSTEM JGS BECKMAN COULTER, INC. NA NA

    Patients

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