BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2250566 · Received September 16, 2011

    Report

    Report Number
    2050012-2011-05570
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 16, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 AND FOUND THE FITTING FOR TUBING 213 ON THE FLUID DISTRIBUTION MANIFOLD WAS LEAKING. THE FSE REPLACED THE FITTING. NO FURTHER LEAKS WERE OBSERVED IN THE INSTRUMENT. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES PRIOR TO RETURNING IT INTO SERVICE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING A LEAK THAT WAS COMING FROM THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED IN THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1