• 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 CGM SENSOR 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 CGM SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number ALL NEW SENSORS
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Rash (2033)
Event Date 07/01/2020
Event Type  Injury  
Event Description
I am a type 1 diabetes patient and have had diabetes for about 10 years. For the past few years i have been using a dexcom g6 continual glucose monitor. Recently dexcom changed their adhesive material - i suspect they did this to reduce the number of replacement sensors they would send to patients (free of charge to the patient) when the sensor adhesive failed to last the sensors life cycle of 10 days. I have had serious adverse reactions to this new adhesive, it appears to be contact dermatitis. Prior to this, i have never had any sort of allergic reaction to any adhesive, including the old dexcom sensor adhesives. Now i would not consider myself to have sensitive skin, and it appears i am not the only patient encountering this. A (b)(6) search revealed a number of forums with other patients seeing the same issue, as well as a (b)(6) petition being filed (b)(6). The reaction i am experiencing seems even more severe than the person who filed the petition. I'm all for strong adhesion since these sensors are quite expensive even with insurance, but it seems like a material group of patients are experiencing these negative side effects. My stomach is only so large, and the site that i'm placing the sensor on usually needs about 2 weeks to heal before i can use that site again for a new sensor. I'll be running out of stomach space soon so i've now had to resort to buying additional skin protecting films ((b)(6)) out of pocket to act as a barrier between my skin and the adhesive. I hope that this will work, otherwise i will have stop using a continual glucose monitor or switch to a different manufacturer. Unfortunately in my opinion, the dexcom product and smart phone application are superior (and they know this). Of course the end result is less controlled blood sugar which will have obvious impacts to my health. Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDEXCOM G6 CGM SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10459490
MDR Text Key204920555
Report NumberMW5096296
Device Sequence Number1
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 08/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberALL NEW SENSORS
Device Catalogue NumberALL NEW SENSORS
Device Lot NumberALL NEW SENSORS
Was Device Available for Evaluation? Yes
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

-
-