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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number DEXCOM G6
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Skin Disorders (4543)
Event Date 02/26/2021
Event Type  Injury  
Event Description
I've been using dexcom continuous glucose monitor's, cgm, since 2017. No health side effects until i retired in (b)(6) 2021 and began walking 5 miles per day (roughly 5 times each week). The significant to severe contact dermatitis happened in (b)(6), 2021 when using 4 consecutive cgm sensors as provided by dexcom (tape/adhesive is the bad actor/culprit) from (b)(6) 2021 until (b)(6) 2021. I now remove and replace the dexcom sensor tape from each new sensor and attach an approved off the shelf medical tape (opsite flexifit tape) in it's place. The newly attached tape has to carefully and permanently be attached to the new sensor module with a specialty adhesive. This tape replacement (opsite flexifit tape) allows me to use the dexcom g6 sensor/cgm without any contact dermatitis side effects that was significant to severe when using the g6 sensor with dexcom tape attached as received from the dexcom. There are many reports and photos of people developing these significant skin rashes from the dexcom tape system. Often, significant modifications are taken from those effected individuals in order for them to keep using the dexcom cgm's. Check out the (b)(4) group called "dexcom and libre rash" group. It's a group for people who are dealing with contact dermatitis (skin rash) from dexcom and abbott libre cgm's. There are a few other websites that have users who post comments, questions and solutions regarding the same skin rash topic from the dexcom and libre cgm's. I am a type 1/insulin dependent diabetic ((b)(6)) and also a retired research technician with (b)(6) of combined experience with a global adhesive manufacturer, (b)(4) and a medical device company (boston scientific). I have no known/diagnosed allergies or sensitivities. I've been tested for allergies at the university of minnesota clinic, the (b)(6) hospital and the (b)(6) clinic when battling a chronic sinus infection. That's another discussion of how i resolved that chronic sinus infection using a dollar store hand soap to kill the infecting agent in my sinus cavity. Please contact me with any questions you have regarding the contact dermatitis adverse reactions from the dexcom g6 cgm's in 2021. Dexcom assigned case # (b)(6). The contact dermatitis was determined to be caused by the dexcom g6 tape by simple deduction. I used the opsite flexifit tape as an overlay tape in order to ensure my cgm would stay attached for the 10 day use period. The contact dermatitis was only present underneath the dexcom tape and never under the opsite flexifit tape. The opsite flexifit tape also covered a wider area of skin to ensure cgm securement. I even placed a 10x7cm film of opsite flexifit tape to my skin as a barrier underlayer and then applied the dexcom g6 cgm with it's tape on top of the barrier layer hoping this would prevent the skin rash. Unfortunately, the skin rash was once again only present underneath the dexcom tape and never the larger flexifit tape, except where the dexcom tape/cgm was attached to the barrier tape (optsite flexifit tape). I was a participant in the mayo clinic international diabetes closed loop clinical study). Fda safety report id # 567667(b)(6).
 
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Brand NameDEXCOM G6 SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11975626
MDR Text Key256456817
Report NumberMW5101804
Device Sequence Number1
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/08/2021
4 Devices were Involved in the Event: 1   2   3   4  
1 Patient was Involved in the Event
Date FDA Received06/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDEXCOM G6
Device Catalogue Number9500-45
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: 06/09/2021 Patient Sequence Number: 1
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