• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 SENSORS SENSOR, GLUCOSE, INVASIVE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEXCOM, INC. DEXCOM G6 SENSORS SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number G6
Device Problem Product Quality Problem (1506)
Patient Problems Erythema (1840); Irritation (1941); Itching Sensation (1943); Swelling (2091); Reaction (2414)
Event Date 06/12/2020
Event Type  Injury  
Event Description
As a type 1 diabetic, i use dexcom g6 sensors to monitor my blood sugar levels. I've used dexcom products for six years, but i've started continuously experiencing adverse side effects from the product as of 1. 5 months ago. The blood sugar sensor is attached to my skin through a small oval of gauze with an adhesive to make sure it stays attached to my body for 10 days. For the past six sensor applications, as soon as i attach the gauze with adhesive to my stomach, the skin underneath and around the application site immediately break out into small, red bumps which become incredibly itchy and irritating. The irritating sensation lasts the entire 10 days in which the sensor is attached to my skin. When i remove the gauze and adhesive, the skin underneath is bright red, covered in bumps, and dry. The dryness and irritation lasts approximately one week after i remove the sensor. I have tried changing the positions in which i apply the sensor, and the same result happens in every location. Because of this, my abdomen is covered in red, irritating, dry patches. I need the sensor to accurately monitor my blood sugar, but these side effects are making it very difficult to do so. I believe dexcom changed the adhesive on their gauze and now my skin is having an adverse reaction to the adhesive. Fda safety report id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDEXCOM G6 SENSORS
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10189043
MDR Text Key196414500
Report NumberMW5095166
Device Sequence Number3
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/19/2020
6 Devices were Involved in the Event: 1   2   3   4   5   6  
0 Patients were Involved in the Event:
Date FDA Received06/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG6
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

-
-