BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX5CE CLINICAL ANALYZER

    MDR report key: 2497690 · Received March 20, 2012

    Report

    Report Number
    2050012-2012-00733
    Event Type
    Malfunction
    Date Received
    March 20, 2012
    Date of Event
    February 15, 2012
    Report Date
    February 21, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K926060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THREE ADDITIONAL MEDICAL DEVICE REPORTS WERE FILED FOR THE SAME INSTRUMENT ISSUE AS: MDR #2050012-2012-00734 (BECKMAN COULTER, INC. REPORT IDENTIFIER (B)(4)) FOR RESULTS GENERATED ON (B)(4) 2012, MDR #2050012-2012-00735 (BECKMAN COULTER, INC. REPORT IDENTIFIER (B)(4)) FOR RESULTS GENERATED ON (B)(4) 2012, AND MDR #2050012-2012-00736 (BECKMAN COULTER, INC. REPORT IDENTIFIER (B)(4)) FOR RESULTS GENERATED ON (B)(4) 2012. (NOTE: THE BECKMAN COULTER, INC. IDENTIFIER FOR THIS REPORT IS (B)(4).)

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT THE SYNCHRON CX5CE CLINICAL ANALYZER INTERMITTENTLY GENERATED ERRONEOUS SODIUM RESULTS. THE SAMPLES WERE RE-RUN AFTER THE SYSTEM WAS RECALIBRATED, AND THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY; THEREFORE, PATIENT TREATMENT WAS NOT AFFECTED. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND REPLACED THE SODIUM MEASURING AND REFERENCE ELECTRODES. THE FSE THEN VERIFIED INSTRUMENT PERFORMANCE TO ENSURE THAT THE SERVICES PERFORMED EFFECTIVELY RESOLVED THE INSTRUMENT ISSUE. CUSTOMER HAS NOT CALLED BACK TO REPORT ANY FURTHER ISSUES RELATING TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX5CE CLINICAL ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER, INC. CX5CE

    Patients

    Seq Age Sex Outcome Treatment
    1