BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3900849 · Received June 27, 2014

    Report

    Report Number
    3004753838-2014-05715
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    April 12, 2014
    Report Date
    May 30, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 AND CLAIMED THAT ON (B)(6) 2014 EXPERIENCED IRRITATION, DEVELOPING INTO A RASH, AROUND SENSOR PATCH ADHESION SITE. PATIENT CLAIMED THAT AFTER SENSOR REMOVAL, THE RASH BEGAN TO SCAR DUE TO PATIENT SCRATCHING THE AREA. PATIENT DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT. DEXCOM TECHNICAL SUPPORT ADVISED PATIENT TO CONSULT A PHYSICIAN, SHOULD THEIR SYMPTOMS NOT SUBSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378182 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other