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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITOR SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number G6
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Irritation (1941); Itching Sensation (1943); Burning Sensation (2146)
Event Date 05/19/2020
Event Type  Injury  
Event Description
I am contacting you regarding the dexcom g6 continuous glucose monitor and the adhesive which was changed at the end of 2019 by the company. For over five years i have been using this product without adverse effects and now, i am experiencing a severe, itching, and burning rash. Several members in a dexcom (b)(6) group have posted photos and reported the same irritation. We have received no word from the company on how they are addressing this issue. I am writing the fda as an advocate and also for help for this severe problem because i have been prescribed a cgm by my doctor to keep me from experiencing low glucose levels. It is a medical necessity and yet it is causing me severe burning and irritation. I have photos and have contacted dexcom but their only offer is to replace the device with the very same adhesive. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6 CONTINUOUS GLUCOSE MONITOR SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10096361
MDR Text Key193006477
Report NumberMW5094728
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 05/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/24/2020
Device Model NumberG6
Device Lot Number5265569
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

Patient Treatment Data
Date Received: 05/27/2020 Patient Sequence Number: 1
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