BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3870848 · Received June 12, 2014

    Report

    Report Number
    3004753838-2014-05677
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    April 22, 2014
    Report Date
    May 19, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    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 PATIENT EXPERIENCED SKIN IRRITATION, AND DEVELOPED A RASH AT SENSOR PATCH ADHESION SITE AND SURROUNDING AREA. AGAINST USER GUIDE RECOMMENDATIONS, PATIENT'S MOTHER STATED THAT PATIENT APPLIED SENSOR PATCH TO ARM. PATIENT'S MOTHER STATED THAT MEDICAL INTERVENTION BY A GENERAL PHYSICIAN WAS SOUGHT ON (B)(6) 2014, AND SKIN OINTMENT WAS PRESCRIBED. NO FURTHER MEDICAL INTERVENTION WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347665 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS, PRODUCT CODE: MDS MDS DEXCOM, INC. 9500-27

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other