BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 1882999 · Received October 26, 2010

    Report

    Report Number
    2050012-2010-01076
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) NOTED THE NEW PROBE TUBING WAS LEAKING AND REATTACHED TUBING.

    Description of Event or Problem · 1

    A FIELD SERVICE ENGINEER (FSE) WAS REPAIRING THE SYSTEM AND FOUND SAMPLE PROBE LEAKING FROM TOP OF PROBE. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1