BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® 20 PRO CLINICAL SYSTEM

    MDR report key: 2003422 · Received March 1, 2011

    Report

    Report Number
    2050012-2011-00593
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) FOUND FLOODING FROM THE CAP PIERCER. THE FSE FOUND AND REMOVED A PIECE OF WICK IN THE DRAIN LINE, AND REPLACED WORN MIXER PADDLE. AS OF (B)(4) 2011, THE INSTRUMENT WAS RETURNED TO BCI.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AUTO GLOSS LEAKING FROM SYNCHRON LX 20 PRO CLINICAL SYSTEM. NO INJURY WAS REPORTED AND THERE WAS NO EFFECT TO PATIENTS OR USERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX® 20 PRO CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. LX 20 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1