BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 600 ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 2110549 · Received June 1, 2011

    Report

    Report Number
    2122870-2011-01636
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS NOT QUESTIONING ANY PATIENT RESULTS. NO SYSTEM PERFORMANCE INFORMATION WAS SUPPLIED BY THE CUSTOMER. SERVICE WAS DISPATCHED AND ON-SITE FOR THIS EVENT ON (B)(4) 2011, AND THE FIELD SERVICE ENGINEER (FSE) FOUND LEAK IN HYDRO. THE FSE REPLACED THE WASH BUFFER PERI-PUMP TUBING. HARDWARE WAS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) IN REGARDS TO A LEAK FROM UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER STATED THAT THE LEAK WAS IN THE PERISTALTIC PUMP AREA OF THE INSTRUMENT, ON TOP OF THE WASTE BOTTLES. THE CUSTOMER HAS A FLOOR DRAIN, AND HAD BEEN WIPING UP FLUID WEARING PPE. THE CUSTOMER ALSO HAS AN EXPOSURE PLAN IN PLACE FOR THE LAB. THERE WAS NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 600 ACCESS® IMMUNOASSAY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXI 600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1