BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 IMMUNOASSAY SYSTEM (W/ DUAL GANTRY)

    MDR report key: 2200446 · Received August 11, 2011

    Report

    Report Number
    2122870-2011-02803
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON-SITE (B)(4) 2011. FSE DISCOVERED LEAKING WASTE PUMP TRANSFER PERI-PUMP TUBING IN THE FLUIDICS DRAWER. FSE REPLACED ALL OF THE PERI-PUMP TUBING AND PRIMED THE INSTRUMENT. NO ISSUES WERE NOTED. HARDWARE IS THE ROOT CAUSE OF THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC)REPORTING THAT THERE WAS A LIQUID LEAKING INTO THE WASTE DRAWER UNDER THE UNICEL DXI 800 IMMUNOASSAY SYSTEM. THIS INSTRUMENT IS PLUMBED TO A FLOOR DRAIN. THE LEAK UNDER THE INSTRUMENT WAS CLEANED PER LABORATORY PROCEDURE. NO INJURY OR USER EXPOSURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 IMMUNOASSAY SYSTEM (W/ DUAL GANTRY) CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1