BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2179297 · Received July 26, 2011

    Report

    Report Number
    2050012-2011-03308
    Event Type
    Malfunction
    Date Received
    July 26, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2011 AND INSPECTED THE INSTRUMENT AND NOTED THE EXPANSION CHAMBERS WERE ORIENTED WITH THE DRAIN AT THE 5 O'CLOCK POSITION AND HAD FLUID IN IT. PER CUSTOMER, THE PREVIOUS WEEK WAS QUITE HUMID. FSE CLEANED OUT THE EXPANSION CHAMBERS AND CHECKED FOR LOOSE TUBING/FITTINGS AND NONE WERE FOUND. FSE SUSPECTED AN ENVIRONMENTAL ISSUE (HUMIDITY). FSE PERFORMED CALIBRATIONS AND TESTED QC. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING A FLUID LEAK THAT WAS COLLECTING UNDER THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER WAS UNABLE TO IDENTIFY THE SOURCE BUT STATED THAT IT APPEARED TO BE WASTE FLUID. NO INJURY WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    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. DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1