BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 PRO SYNCHRON SYSTEM

    MDR report key: 4201321 · Received October 27, 2014

    Report

    Report Number
    2050012-2014-00462
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 27, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K103842
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE EVALUATED THE INSTRUMENT AND FOUND A LEAK AT THE RATIO PUMP AND A TORN FLAPPER ON THE ELECTROLYTE INJECTION CUP (EIC) VALVE . THE FIELD SERVICE ENGINEER REPLACED THE RATIO PUMP AND EIC VALVE TO RESOLVE THE ISSUE. THE FIELD SERVICE ENGINEER VERIFIED INSTRUMENT OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ELEVATED NA (SODIUM), CO2 (CARBON DIOXIDE), CL (CHLORIDE), K (POTASSIUM) AND/OR CALC (CALCIUM) RESULTS FOR SIX (6) PATIENTS, INVOLVING THE UNICEL DXC 800 PRO SYNCHRON SYSTEM. THE CUSTOMER REPEATED THE SAMPLES ON ANOTHER DXC AND OBTAINED LOWER NA, CL, CO2, K, AND CALC RESULTS. THE ELEVATED NA, CL, CO2, K AND CALC RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. QUALITY CONTROL WAS WITHIN LABORATORY'S ESTABLISHED RANGES ON THE DAY OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683131 UNICEL DXC 800 PRO SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR