BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 PRO SYNCHRON SYSTEM

    MDR report key: 4252295 · Received November 14, 2014

    Report

    Report Number
    2050012-2014-00501
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 22, 2014
    Report Date
    October 22, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JGS
    PMA / PMN Number
    K103842
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONFIRMED CONTAMINATION IN THE FLOW CELL BASED ON THE CULTURE RESULT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND EVALUATED THE DEVICE. THE FSE PERFORMED PM C AND PM D [PREVENTIVE MAINTENANCE, ION-SELECTIVE ELECTRODE (ISE) AND MODULAR CHEMISTRY (MC) CUPS] AND REPLACED MULTIPLE ISE HARDWARE COMPONENTS [RATIO PUMP, REFERENCE ELECTRODE, ISE TUBING, EIC (ELECTROLYTE INJECTION CUP) VALVES, EIC DIAPHRAGM AND CARBON BRIDGE] TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNICEL DXC 600 PRO SYNCHRON SYSTEM GENERATED TWO FALSE HIGH SODIUM (NA) RESULTS. THE CUSTOMER VERBALLY PROVIDED SODIUM RESULTS FROM TWO PATIENTS. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO IMPACT TO PATIENT TREATMENT. THE CUSTOMER WAS NOT AWARE OF ANY PATIENT TREATMENT AFFECTED. CONTROLS (QC) RUN BEFORE AND AFTER THE EVENT WERE WITHIN LAB-ESTABLISHED RANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738654 UNICEL DXC 600 PRO SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1