BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2165850 · Received July 17, 2011

    Report

    Report Number
    2050012-2011-03214
    Event Type
    Malfunction
    Date Received
    July 17, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER IDENTIFIED THE SOURCE OF LEAK AS DISCONNECTED TUBING WITHIN THE ISE MODULE BUT WAS UNABLE TO RECONNECT THE TUBING AND A SERVICE REQUEST WAS GENERATED BY BEC CTS (CUSTOMER TECHNICAL SUPPORT). THE CUSTOMER LATER CALLED BEC CTS AND CANCELED THE SERVICE REQUEST SINCE THEY WERE ABLE TO RECONNECT TUBING THAT WAS LEAKING AND PERFORMED CALIBRATION AND QC. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT A LARGE AMOUNT OF FLUID WAS POOLING UNDER THE ISE (ION-SELECTIVE ELECTRODE) AREA ON THE DRAIN TRAY IN THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM AND OVERFLOWING THE TRAY. NO INJURY WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1