BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2260112 · Received August 26, 2011

    Report

    Report Number
    2050012-2011-04819
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Date of Event
    October 7, 2008
    Report Date
    October 7, 2008
    Manufacturer
    BECKMAN COULTER, INC
    Product Code
    JJE
    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. NO CULTURES OF THE SYSTEM WERE TAKEN OR PROVIDED. THE FSE REPLACED THE SAMPLE PROBE, FLOW CELL, SODIUM ELECTRODES AND STRUCK THE CARBON BRIDGE. THE SYSTEM WAS THEN STABILIZED, CALIBRATED AND COMPARED TO ANOTHER SYSTEM IN THE LABORATORY. QUALITY CONTROLS WERE WITHIN SPECIFICATION. ALTHOUGH 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 (B)(6) 2008 AND (B)(6) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AN UNSPECIFIED NUMBER OF ERRONEOUSLY LOW SODIUM RESULTS WERE GENERATED BY THE UNICEL DXC 600 SYNCHRON SYSTEM. CALIBRATION AND QUALITY CONTROLS WERE RUN AT MIDNIGHT AND WERE WITHIN SPECIFICATION PRIOR TO THE EVENT. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SYSTEM WAS RECALIBRATED AND RETURNED TO NORMAL OPERATION. ALL SAMPLES WITH LOW SODIUM RESULTS WERE RETESTED AND THE RESULTS WERE REPORTED. THERE WERE NO CHANGES TO THE PTS' CARE OR TREATMENT RELATED TO THIS EVENT. 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 JJE BECKMAN COULTER, INC NA NA

    Patients

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