BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL ¿ DXI 800 ACCESS ® IMMUNOASSAY SYSTEM

    MDR report key: 2152390 · Received July 7, 2011

    Report

    Report Number
    2122870-2011-01972
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT QUESTION ASSAYS OR PATIENT RESULTS. ON (B)(4) 201 A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND A DEFECTIVE WASH BUFFER RESERVOIR FLOAT SENSOR. FSE REPLACED FLOAT SENSOR AND VERIFIED SYSTEM PERFORMANCE TO PUBLISHED SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) TO REPORT A FLUID LEAK UNDER THE INTERNAL WASH BUFFER RESERVOIR ON THE UNICEL DXI800 ACCESS IMMUNOASSAY ANALYZER. THE CUSTOMER ALSO REPORTED TO HAVE RECEIVED WASH BUFFER TO UPPER RESERVOIR FAILURE ERROR MESSAGE. THE CUSTOMER IS UNABLE TO GET THE INSTRUMENT TO SYSTEM INITIALIZE INTO READY. THE CUSTOMER WORE PERSONAL PROTECTIVE EQUIPMENT. NO INJURY OR EXPOSURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL ¿ DXI 800 ACCESS ® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1