BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2367939 · Received December 12, 2011

    Report

    Report Number
    2050012-2011-08385
    Event Type
    Malfunction
    Date Received
    December 12, 2011
    Date of Event
    November 20, 2011
    Report Date
    November 21, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011 CUSTOMER REPORTED THAT THE DXC 600 PRO INSTRUMENT GENERATED HYDRO ERRORS, AND HAD LEAKED THE DAY BEFORE. CUSTOMER STOPPED AND HOMED THE INSTRUMENT AND IT WAS IN STANDBY. CUSTOMER CLEANED THE SPILL WITH TOWELS. NO INJURIES WERE REPORTED AND NO ERRONEOUS PATIENT RESULTS WERE GENERATED. CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING AND THE CUSTOMER FOUND SOME MOISTURE IN BETWEEN ONE CUVETTE AND THE WALL OF THE REACTION WHEEL. CTS SUSPECTED IT HAPPED WHEN THE CUSTOMER HAD HYDRO ERRORS. CUSTOMER REINSTALLED THE REACTION WHEEL AND INITIALIZED THE WHEEL. NO TEMPERATURE ERRORS WERE OBSERVED, AND CUSTOMER WASHED ALL CUVETTES. NO FURTHER LEAKING WAS OBSERVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1