BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX20 PRO CLINICAL CHEMISTRY SYSTEMS

    MDR report key: 2252182 · Received September 16, 2011

    Report

    Report Number
    2050012-2011-05486
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 21, 2011
    Report Date
    August 21, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K014034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: SLIMY RESIDUE IN GRAVITY DRAIN CANISTER AND ON FLOAT SWITCH. BECKMAN COULTER IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011 CUSTOMER REPORTED THAT WASH CONCENTRATE APPEARED TO BE LEAKING OUT OF THE HYDROPNEUMATICS ON THE LX20 PRO. THE INSTRUMENT IS FULLY FUNCTIONAL AND NO PATIENT RESULTS WERE AFFECTED. CUSTOMER CLEANED THE SPILL WEARING GLOVES AND LAB COAT. NO INJURIES WERE REPORTED. FIELD SERVICE ENGINEER (FSE) EXAMINED THE INSTRUMENT AND REMOVED THE BACK COVER FOR ACCESS TO THE GRAVITY DRAIN. FSE FOUND SLIMY RESIDUE IN THE GRAVITY DRAIN CANISTER AND ON THE FLOAT SWITCH. RESIDUE WAS CLEANED OUT OF CANISTER AND ON FLOAT SWITCH, AND PROPER OPERATION OF THE INSTRUMENT WAS VERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX20 PRO CLINICAL CHEMISTRY SYSTEMS ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. LX20 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1