BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 IMMUNOASSAY SYSTEM

    MDR report key: 2200430 · Received August 11, 2011

    Report

    Report Number
    2122870-2011-02802
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON-SITE (B)(6), 2011. FSE REPLACED BOTH WASH BUFFER PERI-PUMP TUBING AND THE LIQUID WASTE PERI PUMP TUBING. FSE VERIFIED THE LEAK HAD STOPPED BY PRIMING FLUIDICS AND PERFORMING QC WITHIN THE CUSTOMER'S ESTABLISHED RANGES. FSE DID NOT SPECIFY WHICH PART OR PIECE OF THE TUBING WAS THE CAUSE OF THE LEAK BUT IT WAS REPORTED ONLY WASH BUFFER HAD LEAKED FROM THE INSTRUMENT. A DEFINITIVE ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED. THE BEC INTERNAL IDENTIFIER FOR THIS EVENT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REGARDING A WASTE LEAK COMING FROM THE LEFT SIDE OF THE UNICEL DXI 800 IMMUNOASSAY SYSTEM. PER CUSTOMER, THE AMOUNT OF LIQUID WAS LESS THAN 1 LITER. THE SPILL 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 CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1