BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3813394 · Received May 15, 2014

    Report

    Report Number
    3004753838-2014-05577
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    March 22, 2014
    Report Date
    April 16, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 AND CLAIMED THAT ON (B)(6) 2014, UPON SENSOR REMOVAL, SENSOR WIRE WAS LEFT BEHIND IN PATIENT'S BODY. AGAINST USER GUIDE RECOMMENDATIONS, PATIENT REMOVED TRANSMITTER POD BEFORE REMOVING SENSOR WIRE. PATIENT'S MOTHER REPORTED THAT PATIENT WAS NOT EXPERIENCING ANY DISCOMFORT AT INSERTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290095 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS, PRODUCT CODE: MDS MDS DEXCOM, INC. 9500-27 5115230

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other