BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2339893 · Received November 17, 2011

    Report

    Report Number
    2050012-2011-07475
    Event Type
    Malfunction
    Date Received
    November 17, 2011
    Date of Event
    October 17, 2011
    Report Date
    October 17, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BECKMAN COULTER, INC. IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT MICRO TOTAL PROTEIN (MTP) REAGENT FAILED CALIBRATION ON THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. CUSTOMER STATED THAT REAGENT PROBE B WAS FOUND TO BE LEAKING ON THE REAGENT TRAY ABOVE THE REAGENT WHEEL DURING TROUBLESHOOTING. CUSTOMER STATED THAT THE INSTRUMENT WAS STOPPED, AND THAT THE PROBE WAS NOT LEAKING WHILE THE INSTRUMENT WAS IN STOP MODE. CUSTOMER STATED THAT NO PATIENT SAMPLES OR RESULTS WERE AFFECTED, AND THAT NO ONE WAS EXPOSED TO OR HARMED BY THE INSTRUMENT LEAK. THE CUSTOMER TECHNICAL SPECIALIST (CTS) ASSISTED CUSTOMER WITH TROUBLESHOOTING THE INSTRUMENT, AFTER WHICH A SERVICE REQUEST WAS GENERATED. ON THE SAME DAY, THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND FOUND NO LEAKING DURING SYSTEM PRIMING. AFTER HEARING A LOW VACUUM SOUND, THE FSE REPLACED THE WASTE VALVE. THE FSE THEN VERIFIED INSTRUMENT PERFORMANCE TO ENSURE THAT THE SERVICES PERFORMED EFFECTIVELY RESOLVED THE INSTRUMENT LEAK ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1