BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2030107 · Received March 27, 2011

    Report

    Report Number
    2122870-2011-00845
    Event Type
    Malfunction
    Date Received
    March 27, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) REPLACED SOME WORN PERI-TUBING IN THE VACUUM PUMP DRAWER OF THE INSTRUMENT. THE FSE VERIFIED INSTRUMENT PERFORMANCE; NO ISSUES WERE NOTED. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT A LEAK EMANATED FROM THE VACUUM PUMP DRAWER ON THE UNICEL DXI 800 ACCESS CHEMISTRY ANALYZER. 2. NO REPORT OF INJURY TO THE USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1