BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX® I 725 CLINICAL SYSTEM

    MDR report key: 1831462 · Received September 10, 2010

    Report

    Report Number
    2050012-2010-00715
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 13, 2010
    Report Date
    September 10, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT WAS SENT TO THE CUSTOMER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A LEAK ON THE BUNM REAGENT KIT. NO INJURY WAS REPORTED FOR THIS EVENT.

    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. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1