BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3490571 · Received November 26, 2013

    Report

    Report Number
    2050012-2013-00789
    Event Type
    Malfunction
    Date Received
    November 26, 2013
    Date of Event
    November 7, 2013
    Report Date
    November 7, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER'S HOTLINE ADVISED THE CUSTOMER TO PERFORM THE CCWA WASH PROCEDURE FOR ALL CUVETTES AND A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE FOUND WASH SOLUTION UNDER THE REAGENT PROBE A, IN THE COVER DRIP TRAY. HE REPLACED THE A/B REAGENT VALVE (970835) TO ADDRESS THE LEAKING ISSUE. HE ALSO INCIDENTALLY REPLACED THE WASH COLLAR VACUUM VALVES AND TWO SAMPLE SYRINGES. (B)(4).

    Description of Event or Problem · 1

    THE DXC 600I GENERATED ERRONEOUS RESULTS ON MULTIPLE CARTRIDGE CHEMISTRIES FOR 13 PATIENT SAMPLES. ELEVEN OF THOSE RESULTS WERE REPORTED OUTSIDE OF THE LAB. THE CUSTOMER INDICATED ALL PHYSICIANS WERE NOTIFIED. NO RESPONSES ABOUT PATIENT BEING INJURED OR TREATMENT CHANGES DUE TO THE ERRONEOUS RESULTS WERE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616071 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER UNICEL® DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1