BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER WITH SPOT B

    MDR report key: 2110563 · Received June 1, 2011

    Report

    Report Number
    2122870-2011-01642
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS NOT QUESTIONING ASSAYS OR PATIENT RESULTS. SERVICE WAS DISPATCHED AND ONSITE ON (B)(4) 2011. THE FIELD SERVICE ENGINEER (FSE) FOUND LEAKING LIQUID WASTE PERI-PUMP TUBING. THE FSE REPLACED LEAKING TUBING AND VERIFIED SYSTEM PERFORMANCE TO PUBLISHED SPECIFICATIONS. THE FSE COMPLETED AN OVERDUE PREVENTIVE MAINTENANCE ((B)(4) 2011 PM). HARDWARE WAS THE ROOT CAUSE FOR THE EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT A LEAK COMING FROM ABOVE THE LIQUID WASHER CONTAINER ON UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER STATED THAT THERE WAS NO EXPOSURE TO THE LEAKING FLUIDS. NO INJURY WAS REPORTED BY THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1