BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6230880 · Received January 6, 2017

    Report

    Report Number
    3004753838-2017-01077
    Event Type
    Injury
    Date Received
    January 6, 2017
    Date of Event
    October 7, 2016
    Report Date
    December 12, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE USER'S GUIDE STATES: INSERTING THE SENSOR AND WEARING THE ADHESIVE PATCH MIGHT CAUSE INFECTION, BLEEDING, PAIN OR SKIN IRRITATIONS (REDNESS, SWELLING, BRUISING, ITCHING, SCARRING OR SKIN DISCOLORATION).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2016 THAT ON (B)(6) 2016, THAT THE PATIENT EXPERIENCED A SKIN REACTION AT THE ABDOMEN. THE SENSOR WAS INSERTED AT THE ABDOMEN ON (B)(6) 2016. THE REACTION WAS DESCRIBED AS RED, RAISED RASH, RAW, NOT HEALING, A BURNED REACTION THAT SCABS UP, AND TURNING COLORS. FLONASE NASAL SPRAY WAS PRESCRIBED FOR TREATMENT. THE DATE OF PRESCRIPTION IS UNKNOWN. PATIENT'S MOTHER ALSO REPORTED APPLYING FLONASE PRIOR TO SENSOR INSERTION. AT THE TIME OF CONTACT, PATIENT'S RASH IS NOT HEALING. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE PROVIDED FOR EVALUATION. THE REPORTED EVENT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11701 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9500-27 5209485 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other