BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2535814 · Received April 14, 2012

    Report

    Report Number
    2050012-2012-00915
    Event Type
    Malfunction
    Date Received
    April 14, 2012
    Date of Event
    March 20, 2012
    Report Date
    March 20, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM ELECTROLYTE INJECTION CUP (EIC) WAS OVERFLOWING. CUSTOMER REPORTED THAT THERE WAS A CLOT IN THE EIC. CUSTOMER REPORTED THAT THEY WERE RUNNING THE INSTRUMENT IN NORMAL OPERATING MODE WHEN THE OVERFLOW OCCURRED. CUSTOMER REPORTED THAT FLUID WAS ACCUMULATING ON THE FLOOR, UNDER THE CARBON DIOXIDE (CO2) ACID REAGENT, IN THE REAGENT TRAY. CUSTOMER REPORTED THAT ABOUT 50 TO 100 MILLILITERS OF FLUID OVERFLOWED. THERE WAS NO REPORT OF ERRONEOUS RESULTS GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. CUSTOMER REPORTED THAT THEY SUCCESSFULLY CLEANED THE EIC. CUSTOMER REPORTED THAT THEY PERFORMED THE ALIGNMENT FOR SAMPLE PROBE TO EIC AND EIC HEIGHT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening