BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2806302 · Received October 26, 2012

    Report

    Report Number
    2050012-2012-01359
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE PIERCING PROBE OF THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM WAS DRIPPING FLUID. CUSTOMER REPORTED THAT THE WASH STATION WAS SONICATING, BUT FLUID WAS DRIPPING OFF WHEN THE WASH STATION MOVED TO THE LEFT. CUSTOMER INDICATED THE WASH STATION WAS ALMOST OVERFLOWING. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) NOTED FLUID ON THE PIERCING PROBE. THE FSE REPLACED THE PROBE AND PERFORMED ALIGNMENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1