BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2172711 · Received July 22, 2011

    Report

    Report Number
    2050012-2011-03194
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON 06/15/2011 FOR THIS EVENT. THE FSE REPLACED THE SYRINGE 3-WAY VALVE AND COLLAR WASH SOLENOID VALVE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) A LEAK ON A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. SPECIFICALLY, THE CUSTOMER STATED THAT THEY NOTICED A SLOW DRIP THAT APPEARED TO BE COMING FROM THE COLLAR WASH WHICH COULD HAVE AFFECTED QC LEVEL 1 COMING OUT LOW ALTHOUGH NO PATIENT RESULTS WERE INVOLVED. NO ONE WAS EXPOSED TO THE LEAKING FLUID THAT REQUIRED MEDICAL ATTENTION. THE CUSTOMER WAS WEARING A LAB COAT AND GLOVE WHILE TROUBLESHOOTING. NO EFFECT TO PATIENT OR OPERATOR WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1