BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 PRO SYNCHRON SYSTEM

    MDR report key: 4171579 · Received October 14, 2014

    Report

    Report Number
    2050012-2014-00463
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K103842
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RESOLVED THE ISSUE PRIOR TO THE BECKMAN FIELD SERVICE ENGINEER (FSE) ARRIVING TO THE CUSTOMER SITE. THE CUSTOMER RESOLVED THE LEAK BY REPLACING THE CARTRIDGE CHEMISTRY SAMPLE PROBE WASH COLLAR, NO FURTHER LEAKS WERE OBSERVED. THE FSE EVALUATED THE INSTRUMENT AND VERIFIED THE CUSTOMER REPAIRS WHEN ARRIVING ONSITE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE INSTRUMENT GENERATED CARTRIDGE CHEMISTRY (CC) SAMPLE PROBE MOTION ERRORS ON A UNICEL DXC 600 PRO SYNCHRON SYSTEM. UPON TROUBLESHOOTING, THE CUSTOMER OBSERVED A LEAK FROM THE CC SAMPLE PROBE; THE PROBE CONTINUED TO LEAK AFTER THE CUSTOMER PERFORMED A SAMPLE PROBE VERTICAL ALIGNMENT AND PRIMING OF THE INSTRUMENT. THE CUSTOMER VERIFIED THE SAMPLE PROBE TUBING WAS TIGHT, FOUND NO OBSTRUCTIONS IN THE VACUUM LINE, AND DESCRIBED THE VOLUME OF THE LEAK AS A "COUPLE OF DROPS". THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650161 UNICEL DXC 600 PRO SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1