BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO CLINICAL ANALYZER

    MDR report key: 1891539 · Received November 4, 2010

    Report

    Report Number
    2050012-2010-01195
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 7, 2010
    Report Date
    November 4, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER TO OPEN THE ISE COMPARTMENT AND CHECK FOR ANY PRESENT LEAKS, WHILE WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE). THE CUSTOMER NOTED THAT THE BLOOD UREA NITROGEN (BUN) CUP APPEARS TO BE OVERFILLING OR NOT DRAINING. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2010 AND FOUND THE MODULAR CHEMISTRY (MC) SAMPLE PROBE WASH COLLAR VACUUM VALVE WAS NOT OPERATING PROPERLY. THE FSE REPLACED THE VALVE, AND FOUND IT TO BE CLOGGED. THE FSE ALSO FOUND A CLOG IN THE ELECTROLYTE INJECTION CUP (EIC) VALVE WHICH WAS CLEARED. THE SYSTEM IS NOW OPERATING ACCEPTABLY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO FLUID LEAKING ONTO THE FLOOR BELOW THE MODULAR CHEMISTRY (MC) REAGENT COMPARTMENT LOCATED IN THE SYNCHRON LX20 PRO CLINICAL ANALYZER. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED FOR THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1