BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3831083 · Received May 23, 2014

    Report

    Report Number
    3004753838-2014-05620
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 29, 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 FATHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT THAT ON (B)(6) 2014, AFTER INSERTION IN ARM, PATIENT PRESENTED WITH SWELLING AND REDNESS AROUND THE SENSOR. THE DEVICE IS NOT INDICATED FOR USE IN ARM. ON (B)(6) 2014, PATIENT'S FATHER REPORTED PATIENT SAW THE PEDIATRICIAN AND WAS PRESCRIBED ANTIBIOTICS. AT THE TIME OF THE CALL TO DEXCOM TECHNICAL SUPPORT, PATIENT'S FATHER REPORTED THAT THE REDNESS AND SWELLING HAD REDUCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308883 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS, PRODUCT CODE: MDS MDS DEXCOM, INC. 9500-27

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other