BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX®I 725 CLINICAL SYSTEM

    MDR report key: 1960373 · Received January 13, 2011

    Report

    Report Number
    2050012-2011-00119
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS UNABLE TO LOCATE THE SOURCE OF THE LEAK AND SERVICE WAS REQUESTED. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2010. SYSTEM WAS IN USE UPON ARRIVAL. FSE INSPECTED THE INSTRUMENT AND COULD NOT FIND LEAKS. FSE RAN MULTIPLE PRIMES AND WILL MONITOR WITH CUSTOMER FOR ANY MORE FLUID LEAKS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A LIQUID LEAK IN THE HYDRO COMPARTMENT OF THE SYNCHRON LXI 725 CLINICAL SYSTEM. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX®I 725 CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1