BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1882920 · Received October 26, 2010

    Report

    Report Number
    2050012-2010-01080
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED CUSTOMER IN ENSURING ALL TUBING, SYRINGE AND PROBE CONNECTIONS WERE SECURE. CUSTOMER WAS ABLE TO CALIBRATE AND RUN QUALITY CONTROL WITHOUT FURTHER LEAKING. A SERVICE VISIT HAS ALSO BEEN ORDERED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) REGARDING LEAKING FLUID AROUND WASH COLLAR OF A REAGENT PROBE. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1