BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 ANALYZER

    MDR report key: 1883613 · Received October 26, 2010

    Report

    Report Number
    2050012-2010-01054
    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
    K965240
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND 20+ CUVETS OUT OF LIMITS, BUT NO EVIDENCE OF LEAKAGE FORM THE MC SIDE OF THE SYSTEM WAS APPARENT. THE ISSUE COULD POSSIBLY BE A WASH MANIFOLD VALVE MALFUNCTION. THE SYSTEM IS NOW OPERATING WITHOUT ERROR. A NEW MANIFOLD IS ORDERED FOR THE UNIT. INVESTIGATION IS ONGOING REGARDING THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) IN REGARDS TO A FLUID LEAK UNDER THE MODULAR CHEMISTRY (MC) SIDE OF THE SYNCHRON LX20 ANALYZER. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX20 ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. LX 20 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1