BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHON CX DELTA CLINICAL SYSTEM

    MDR report key: 2362423 · Received December 7, 2011

    Report

    Report Number
    2050012-2011-08245
    Event Type
    Malfunction
    Date Received
    December 7, 2011
    Date of Event
    November 10, 2011
    Report Date
    November 11, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K950958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011 CUSTOMER REPORTED THAT THE DAY BEFORE SHE WAS GETTING ERRONEOUS RESULTS ON NA, K, CALC, TP, AND ALB. CUSTOMER STATED THAT THE ELECTROLYTE ISSUE HAD BEGUN BEFORE THE LAST MAINTENANCE WAS PERFORMED AND THE IT STARTED AGAIN 2 WEEKS LATER. CUSTOMER STATED THAT THE CALIBRATIONS AND QUALITY CONTROL FOR ELECTROLYTES WOULD BE OKAY, BUT SOME PATIENTS WERE GIVING PANIC VALUES, WHICH THE CUSTOMER QUESTIONED AND RERAN, THEREBY GETTING NON PANIC VALUE RESULTS. CUSTOMER STATED THAT SOME TP, ALB AND CALC HAD ALSO GIVEN HIGH RESULTS AND RERUNS WERE LOWER. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. FIELD SERVICE ENGINEER (FSE) EXAMINED THE INSTRUMENT ON (B)(4) 2011 AND ISOLATED CX4 SIDE ISSUES TO A REAGENT PROBE LEVEL SENSE PROBLEM. FSE INSTALLED A NEW REAGENT PROBE AND VERIFIED PROPER REAGENT LOADING. FSE FOUND A DEFECTIVE ION SELECTIVE ELECTRODE (ISE) ODC, WHICH CAUSED CALIBRATION FAILURES. FSE ORDERED A NEW COLD PLATE AND ISE ODC FOR RETURN VISIT THE NEXT DAY. FSE RETURNED ON (B)(4) 2011 TO COMPLETE REPAIRS. FSE REPLACED THE ISE ODC AND SUCCESSFULLY CALIBRATED THE ISE CLOT DETECTOR. FSE REPLACED THE CX4 REAGENT CAROUSEL COLD PLATE DUE TO INTERMITTENT PELTIER FAILURE ERROR MESSAGES. FSE PERFORMED ALL NECESSARY ALIGNMENTS/ADJUSTMENTS AND SUCCESSFULLY CALIBRATED AND RAN CONTROLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHON CX DELTA CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. CX5 DELTA

    Patients

    Seq Age Sex Outcome Treatment
    1