BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 2060333 · Received April 15, 2011

    Report

    Report Number
    2122870-2011-01007
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS ON SITE (B)(4) 2011. THE FIELD SERVICE ENGINEER (FSE) ISOLATED THE ISSUE TO THE WASTE CONTAINER LEVEL SENSOR. THE FSE REPLACED THE FAILING WASTE CONTAINER LEVEL SENSOR AND NOTED THE ISSUE WAS RESOLVED. 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 THE LEAK WAS LOCALIZED TO THE WASTE COMPARTMENT OF THE INSTRUMENT. 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