BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO CLINICAL SYSTEM

    MDR report key: 1945120 · Received January 3, 2011

    Report

    Report Number
    2050012-2011-00022
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    November 30, 2010
    Report Date
    December 1, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT REAGENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE ISE BUFFER BOTTLE WAS LEAKING AT THE LID OF THE SYNCHRON LX20 PRO CLINICAL SYSTEM. THE CUSTOMER STATED THAT THE CAP WAS LOOSE ON THE ISE BUFFER BOTTLE. NO INJURY WAS REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX20 PRO CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. LX20 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1