BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 2110529 · Received June 1, 2011

    Report

    Report Number
    2122870-2011-01625
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SYSTEM PERFORMANCE INFORMATION WAS PROVIDED BY THE CUSTOMER. SERVICE WAS ON SITE ON (B)(4) 2011. THE FIELD SERVICE ENGINEER (FSE) FOUND THE WASTE TRANSFER PERI-PUMP TUBING WAS LEAKING, AND REPLACED THE TUBING. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES. HARDWARE WAS THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT A LEAK COMING FROM UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER STATED THERE IS AN EXPOSURE POLICY IN PLACE AT THE FACILITY. THE CUSTOMER WAS ADVISED NOT TO USE THIS INSTRUMENT. THE CUSTOMER STATED THAT NO ONE CAME IN CONTACT WITH THE FLUID AND THERE WAS NO INJURY OR EXPOSURE TO THE FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1