BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2171987 · Received July 15, 2011

    Report

    Report Number
    2050012-2011-03147
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    March 2, 2008
    Report Date
    March 2, 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
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) VISITED THE FACILITY AND EXAMINED THE SYSTEM. CULTURES OF THE SYSTEM WERE TAKEN AND THE RESULTS WERE POSITIVE FOR AN UNSPECIFIED CONTAMINANT. THE FSE REPLACED THE SODIUM ELECTRODE, ASSORTED TUBING AND CLEANED THE FLOWCELL AND THE ELECTROLYTE INJECTION CUP. SUBSEQUENTLY, THE FSE THEN DECONTAMINATED THE SYSTEM. THE FSE OPINES THAT THE SOURCE OF THE CONTAMINANT MAY BE RELATED TO THE CUSTOMER RESTING THE REAGENT STRAW ON THE GROUND, HOWEVER, A DEFINITIVE SOURCE HAS NOT BEEN IDENTIFIED. ALTHOUGH THE SYSTEM WAS DECONTAMINATED AND SEVERAL PARTS WERE REPLACED AND THESE MEASURES 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. THIS REPORT REPRESENTS ONE OF 48 (FORTY-EIGHT) INDIVIDUAL REPORTS AS THE CUSTOMER ADVISED THAT 48 PT RESULTS WERE REPORTED FROM THE LABORATORY THEN CORRECTED RESULTS ISSUED. REFERENCE THE BELOW MDR REPORTS FOR ALL ASSOCIATED EVENTS. MDR #2050012-2011-03141, 03142, 03143, 03144, 03145, 03146, 03148, 03149, 03150, 03151, 03152, 03153, 03154, 03155, 03156, 03157, 03158, 03159, 03160, 03161, 03162, 03163, 03164, 03165, 03166, 03167, 03168, 03169, 03170, 03171, 03172, 03173, 03174, 03175, 03176, 03177, 03178, 03179, 03180, 03181, 03182, 03183, 03184, 03185, 03186, 03187, 03188.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT 48 ERRONEOUSLY LOW SODIUM RESULTS WERE GENERATED BY THE UNICEL DXC 800 SYNCHRON SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY AND THE VALIDITY OF THE RESULTS WAS QUESTIONED BY THE UNIT ATTENDINGS. THE CUSTOMER INITIATED CORRECTIVE ACTIONS BY CLEANING THE FLOW CELL AND CALIBRATING THE ION-SELECTIVE ELECTRODE. THE OPERATOR THEN RETESTED THE SAMPLES ON THE FACILITY'S OTHER SYSTEMS AND OBTAINED RESULTS THAT WERE WITHIN EXPECTATION. CORRECTED RESULTS WERE THEN ISSUED. IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO THE PTS' CARE OR TREATMENT; HOWEVER, THERE IS NO REPORT OF ANY SERIOUS INJURY 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 800 SYNCHRON SYSTEM JJE BECKMAN COULTER, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK