BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2103587 · Received May 26, 2011

    Report

    Report Number
    2122870-2011-01582
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 30, 2011
    Report Date
    April 30, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2011. THE 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. THE FSE VERIFIED HARDWARE BY PERFORMING A PASSING SYSTEM CHECK WITHIN INSTRUMENT SPECIFICATIONS AND QC WITHIN THE CUSTOMER'S ESTABLISHED RANGES. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) AND REPORTED A FLUID LEAK COMING FROM THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THERE WAS 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. NA N/A

    Patients

    Seq Age Sex Outcome Treatment
    1