BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2504530 · Received March 26, 2012

    Report

    Report Number
    2050012-2012-00799
    Event Type
    Malfunction
    Date Received
    March 26, 2012
    Date of Event
    March 1, 2012
    Report Date
    March 1, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    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 FLUID WAS LEAKING FROM THE TOP OF THE CC (CARTRIDGE CHEMISTRY) SAMPLE PROBE OF THE UNICEL DXC 600 SYNCHRON SYSTEM AROUND THE WHITE FITTING THAT CONNECTED THE TUBING TO THE BEAD/PROBE. CUSTOMER REPORTED THAT NO FLUID LEAKED INTO THE INSTRUMENT. CUSTOMER REPORTED THAT THE FLUID STAYED ON THE COVER. CUSTOMER REPORTED THAT THE VOLUME OF THE LEAK WAS ABOUT 2 TO 5 MILLILITERS. CUSTOMER REPORTED THAT THEY BELIEVED THE FITTING CAME LOOSE WHEN THEY CLEANED THE PROBE DURING MAINTENANCE. CUSTOMER REPORTED THAT THEY TIGHTENED THE FITTING AND THE LEAK STOPPED. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1