BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2183546 · Received July 8, 2011

    Report

    Report Number
    2050012-2011-02890
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    March 26, 2008
    Report Date
    March 26, 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
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) VISITED THE FACILITY AND EXAMINED THE SYSTEM. CULTURES OF THE SODIUM ELECTRODE AND PORT SHOWED HEAVY GROWTH OF PSEUDOMONAS SPP. THE FSE DECONTAMINATED THE SYSTEM. THE FSE ALSO REPLACED SEVERAL ELECTRODES. ALTHOUGH THE SYSTEM WAS DECONTAMINATED AND SEVERAL PARTS WERE REPLACED, A SPECIFIC ROOT CAUSE OF THIS EVENT WAS NOT 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 ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ERRONEOUSLY LOW SODIUM RESULTS WERE GENERATED BY THE UNICEL DXC 800 SYNCHRON SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE OPERATOR RECALIBRATED THE SYSTEM AND RETESTED THE SAMPLES. THE RESULTS WERE WITH EXPECTATIONS. CORRECTED RESULTS WERE THEN ISSUED. THERE WAS NO CHANGE TO THE PATIENTS' CARE OR TREATMENT.

    Devices

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

    Patients

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