BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 PRO SYNCHRON SYSTEM

    MDR report key: 4222194 · Received November 3, 2014

    Report

    Report Number
    2050012-2014-00483
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 10, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K103842
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 ISSUE BY TIGHTENING THE TOP CONNECTION FITTING ON REAGENT PROBE A, NO FURTHER LEAKS, INSTRUMENT ERRORS, OR QUALITY CONTROL (QC) RECOVERY ISSUES WERE OBSERVED. THE FSE EVALUATED THE INSTRUMENT AND VERIFIED THE CUSTOMER TIGHTENED REAGENT PROBE A TO RESOLVE THE ISSUES WHEN ARRIVING ONSITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED QUALITY CONTROL (QC) RECOVERY ISSUES FOR URINE AND "CUVETTE NOT DRY BEFORE FIRST REAGENT DISPENSE" ERRORS ON A UNICEL DXC 600 PRO SYNCHRON SYSTEM. UPON TROUBLESHOOTING, THE CUSTOMER OBSERVED A LEAK FROM REAGENT PROBE A (INITIALLY REPORTED INCORRECTLY AS REAGENT PROBE B). THE LEAK WAS CONTAINED TO THE REACTION WHEEL COVER AND REAGENT PROBE DRIP TRAY WITH AN APPROXIMATE VOLUME OF 75ML. THE CUSTOMER STATED A FEW DROPS OF FLUID (DETERMINED TO BE DE-IONIZED WATER) DRIPPED IN THE CUSTOMER'S HAIR WHILE LIFTING THE INSTRUMENT HOOD. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AND VERIFIED NO EXPOSURE, NO INJURIES AND DID NOT SEEK MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703057 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