BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2933797 · Received January 29, 2013

    Report

    Report Number
    2050012-2013-00041
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC CTS (CUSTOMER TECHNICAL SUPPORT) HAD THE CUSTOMER CHECK THE FITTING AND SYRINGE. PER CUSTOMER, BOTH WERE TIGHT. CTS SUGGESTED RESEATING THE FITTING AND THE TUBING TO ENSURE A SEAL ON TOP OF THE REAGENT PROBE A AND A SERVICE VISIT WAS SET UP. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND FSE CONFIRMED THAT THE FAILURE MODE WAS THE R1 WASH VALVE (MANIFOLD VALVE). FSE REPLACED THAT PART AND VERIFIED SYSTEM PERFORMANCE. THE CAUSE OF THE LEAK WAS THE MANIFOLD VALVE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE 'DATE RECEIVED BY MANUFACTURER' WAS INCORRECTLY ENTERED AS (B)(4) 2012 INSTEAD OF (B)(4) 2013. THIS FOLLOW-UP REPORT REFLECTS THE CORRECT YEAR (2013).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) STATING THEY OBSERVED APPROXIMATELY 3 ML OF FLUID UNDER THE REAGENT PROBE A TRAY OF THEIR UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. THE TIP OF THE REAGENT PROBE WAS REPORTED TO BE WET. THE CUSTOMER WAS WEARING A LAB COAT AND GLOVES AT THE TIME OF THE EVENT. NO INJURY OR EXPOSURE WAS REPORTED. THERE WERE NO FLAGS OR INSTRUMENT ERROR MESSAGES AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38790 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1