BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3882074 · Received June 18, 2014

    Report

    Report Number
    3004753838-2014-05698
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 27, 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 RASH AT SENSOR PATCH ADHESION SITE. PATIENT'S MOTHER SOUGHT MEDICAL INTERVENTION ON BEHALF PATIENT AND WAS GIVEN A BARRIER WIPE TO USE BETWEEN SKIN AND SENSOR ADHESIVE. NO FURTHER MEDICAL INTERVENTION WAS NECESSARY. AT THE TIME OF THE CALL WITH DEXCOM TECHNICAL SUPPORT, PATIENT'S MOTHER REPORTED PATIENT WAS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359314 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other