BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 2063602 · Received April 19, 2011

    Report

    Report Number
    2122870-2011-01023
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 20, 2011
    Report Date
    March 20, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS ON SITE (B)(4) 2011. THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THAT THE LEAK WAS COMING FROM THE PERISTALTIC PUMP TUBING RUNNING THROUGH THE WASH BUFFER TRANSFER PUMP. THE FSE REPLACED THE WASH BUFFER TRANSFER PUMP TUBING ALONG WITH ALL OTHER TUBING WITHIN THE FLUIDICS DRAWER OF THE DXI 800. THE FSE ALSO REPLACED ALL ASPIRATE PROBES AND THE ASSOCIATED TUBING. THE FSE VERIFIED HARDWARE BY PERFORMING QC, WHICH WAS WITHIN THE ESTABLISHED RANGES. THE FSE ALSO PERFORMED HSFOAM/NOFOAM TEST, AND THE RESULTS WERE WITHIN INSTRUMENT SPECIFICATIONS. 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. THERE WAS NO EXPOSURE TO THE LEAK AND NO REPORT OF INJURY.

    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