BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO CHEMISTRY ANALYZER

    MDR report key: 1883593 · Received October 26, 2010

    Report

    Report Number
    2050012-2010-01055
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 26, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE TUBE THAT RUNS TO THE WASH CONCENTRATE VALVE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) REGARDING THE WASH CONCENTRATE CANISTER WAS NOT FILLING ON THE SYNCHRON LX20 PRO CHEMISTRY ANALYZER AND WAS LEAKING. NO INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1