BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 3951463 · Received July 22, 2014

    Report

    Report Number
    2050012-2014-00349
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) FOUND INCORRECTLY ROUTED ION-SELECTIVE ELECTRODE TUBING CAUSED BY USE ERROR BY THE FSE DURING A PREVENTIVE MAINTENANCE PERFORMED ON (B)(4) 2014. THE FIELD SERVICE ENGINEER ALSO FOUND CORROSION ON THE SAMPLE SYRINGE, "BLUE SLIME" (PROTEIN BUILDUP) IN THE FLOWCELL AND AN INTERMITTENTLY OPERATING WASH COLLAR VALVE. THE FIELD SERVICE ENGINEER REPLACED THE SYRINGE, CARBON BRIDGE, WASH COLLAR VALVE, DISASSEMBLED AND CLEANED THE FLOW CELL AND CORRECTLY ROUTED ALL FLUIDIC LINES TO RESOLVE THE ISSUE AND VERIFIED INSTRUMENT PERFORMANCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ERRATIC ION-SELECTIVE ELECTRODE RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER PROVIDED ONE VERBAL EXAMPLE OF A NA (SODIUM) RESULT OF 138 MMOL/L THAT WAS REPEATED ON ANOTHER DXC AND OBTAINED A RESULT OF 129 MMOL/L. A SECOND REPEAT ON THE SAME DXC GAVE A RESULT OF 130 MMOL/L. RESULTS WERE NOT REPORTED OUT OF THE LAB. THE REMOTE MANAGEMENT SYSTEM REVEALED THAT ALTHOUGH QUALITY CONTROL WAS WITHIN THE LABORATORY'S ESTABLISHED RANGES ON THE DATE OF THE EVENT, RECOVERIES HAD BEEN ERRATIC STARTING (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428778 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1