BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2211019 · Received August 13, 2011

    Report

    Report Number
    2050012-2011-04455
    Event Type
    Malfunction
    Date Received
    August 13, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 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
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER FOUND AND CORRECTED A LOOSE FITTING ON THE REAGENT SYRINGE 3-WAY VALVE. SERVICE WAS NOT NEEDED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT THAT REAGENT WASH COLLARS FROM A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM WERE LEAKING. THE CUSTOMER STATED THAT NO ERRONEOUS PATIENT RESULTS WERE GENERATED. 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