BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 3000577 · Received March 12, 2013

    Report

    Report Number
    2050012-2013-00127
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE VISIT WAS SET UP HOWEVER THE CUSTOMER RESOLVED THE ISSUE PRIOR TO THE ARRIVAL OF THE FSE. THE CUSTOMER FOUND A LOOSE FITTING ON TOP OF THE REAGENT PROBE (WHERE TUBING ATTACHES TO THE PROBE). THE CUSTOMER TIGHTENED THE FITTING WHICH RESOLVED THE LEAK. THE FIELD SERVICE ENGINEER (FSE) PERFORMED MAINTENANCE ON THE INSTRUMENT. THE CAUSE OF THE LEAK IS ATTRIBUTED TO THE LOOSE TUBING ON TOP OF THE REAGENT PROBE B. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT THAT REAGENT PROBE B OF AN UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM WAS LEAKING FROM THE BOTTOM OF THE WASH COLLAR. THE CUSTOMER STATED THAT FLUID HAD DRIPPED INTO THE REAGENT COMPARTMENT AND ONTO THE REACTION WHEEL COVER. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT. NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS RESULTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104165 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1