BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 1960404 · Received January 13, 2011

    Report

    Report Number
    2050012-2011-00128
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 19, 2010
    Report Date
    December 19, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COULD NOT LOCATE THE SOURCE OF THE LEAK. A FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND CONFIRMED THAT THE CLOSED TUBE ALIQUOTTER (CTA) WAS HAVING LEVEL SENSING ISSUE AND PROBE LEAKING WASH. FSE PERFORMED REPAIRS AS NEEDED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THERE WAS A LEAK INSIDE THE CLOSED TUBE ALIQUOTTER (CTA) SAMPLING AREA. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1