BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3833977 · Received May 27, 2014

    Report

    Report Number
    3004753838-2014-09337
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 30, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN INTERNATIONAL DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT HARDWARE FAILURE ON (B)(6) 2014 ON BEHALF OF A PATIENT. AT THE TIME OF THE CALL, DEXCOM TECHNICAL SUPPORT ADVISED THE DISTRIBUTOR TO RESET THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310588 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649-2 5067209

    Patients

    Seq Age Sex Outcome Treatment
    1 Other