BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3230394 · Received July 16, 2013

    Report

    Report Number
    3004753838-2013-00189
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    May 12, 2013
    Report Date
    June 17, 2013
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT'S PARENTS CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013 TO REPORT THAT ON (B)(6) /2013, PATIENT EXPERIENCED A RASH UNDER THE SENSOR ADHESIVE PATCH. PATIENT EXPERIENCED A SIMILAR RASH ON ANOTHER SENSOR INSERTED ON (B)(6) 2013. PATIENT CONSULTED WITH A PHYSICIAN FOR A REGULARLY-SCHEDULED APPOINTMENT ON (B)(6) 2013. PHYSICIAN REFERRED PATIENT TO AN ALLERGIST FOR THE RASH. THE PATIENT HAS CONSULTED WITH THE ALLERGIST APPROXIMATELY FIVE TIMES SINCE (B)(6) 2013. THE ALLERGIST DID TESTING AND PRESCRIBED A TOPICAL STEROID CREAM. AT THE TIME OF THEIR CALL TO DEXCOM TECHNICAL SUPPORT, PATIENT'S PARENTS REPORTED THAT PATIENT STILL HAS A MARK AT THE SENSOR SITE, BUT IS IN HEALTHY CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329046 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5058593

    Patients

    Seq Age Sex Outcome Treatment
    1 22 MO Other