BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1837548 · Received September 16, 2010

    Report

    Report Number
    2050012-2010-00786
    Event Type
    Malfunction
    Date Received
    September 16, 2010
    Date of Event
    August 22, 2010
    Report Date
    September 16, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HOTLINE ADVISED CUSTOMER TO WEAR PPE BEFORE TROUBLESHOOTING. NO-FOAM BOTTLE ASSEMBLY WAS SENT TO THE CUSTOMER FOR REPLACEMENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) AND REPORTED THAT NO-FOAM REAGENT WAS LEAKING FROM THE CANISTER CAP FITTING. THE CUSTOMER REPLACED THE NO-FOAM BOTTLE ASSEMBLY AND THE SYSTEM RESUMED. NO INJURY WAS REPORTED. CUSTOMER WAS WEARING PPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600

    Patients

    Seq Age Sex Outcome Treatment
    1