BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4130500 · Received September 30, 2014

    Report

    Report Number
    3004753838-2014-29330
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 AND CLAIMED THAT PATIENT EXPERIENCED RASH AT SENSOR PATCH ADHESION SITE ON (B)(6) 2014. PATIENT'S MOTHER CONSULTED WITH DERMATOLOGIST AND WAS ADVISED TO FIND OUT INGREDIENTS OF ADHESIVE. PATIENT'S MOTHER DID NOT REPORT ANY INJURY OR FURTHER MEDICAL INTERVENTION AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609550 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR