BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3853045 · Received June 6, 2014

    Report

    Report Number
    3004753838-2014-09428
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A DOMESTIC DISTRIBUTOR CONTACTED DEXCOM ON (B)(6) 2014 AND CLAIMED THAT ON (B)(6) 2014 THEY WERE CONTACTED BY A PATIENT WHO EXPERIENCED A HARDWARE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333114 SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM MDS, PRODUCT CODE: MDS MDS DEXCOM, INC. 9431-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other