BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX3 DELTA

    MDR report key: 2192053 · Received August 4, 2011

    Report

    Report Number
    2050012-2011-03890
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJF
    PMA / PMN Number
    K950958
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER REPLACED THE DRAIN LINE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) TO REPORT AN UNKNOWN FLUID LEAK FROM INSIDE THE CHEMISTRY COMPARTMENT ON THE SYNCHRON CX3 DELTA. A CUSTOMER TECHNICAL SUPPORT ADVISED THE CUSTOMER TO NOTIFY THEIR STAFF AND STOP USING THE SYSTEM. NO INJURY OR EXPOSURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX3 DELTA MICRO CHEMISTRY ANALYZER FOR CLINICAL USE JJF BECKMAN COULTER INC. CX3 DELTA N/A

    Patients

    Seq Age Sex Outcome Treatment
    1