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U.S. Department of Health and Human Services

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

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DEXCOM INC DEXCOM G6 SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Pain (1994); Scarring (2061); Skin Irritation (2076); Reaction (2414); Caustic/Chemical Burns (2549); Blood Loss (2597)
Event Date 03/18/2020
Event Type  Injury  
Event Description
Decreased qol/ compliance; i wear a dexcom g6 continuous glucose monitor for diabetes management. A couple of months ago i noticed that my skin was having a bad reaction to the site. I have worn the dexcom g6 for 3+ years and have never had an issue before. I later came to find that dexcom has changed their adhesive to "make the sites stay in place longer". Prior to this change i had never had any issues with the adhesive not sticking properly. Now, the dexcom sites cause what looks like a chemical burn on my skin, the area is extremely itchy, and painful, and removing the site also removes the top layer of my skin causing it to bleed and leave scars. This product is meant to be worn for 10 days at a time. I cannot wear the site for more than 2 days max because of the severe reaction. This means that i go long periods of time without supplies because my insurance only covers so much at a time. I have attempted multiple different techniques to try and protect my skin from this adhesive including; visiting a dermatologist, using skin barriers such as skintac, and tegaderm pads, and also attempting to keep the site dry and covered from the sun to name a few. Prior to the changes in the adhesive, i was a proud user of the dexcom g6. At this time, i cannot wear this product and it has greatly impacted my quality of life as well as my ability to take care of myself and my diabetes. I am also aware that i am not the only customer experiencing these problems. I, as well as many others, would like it if dexcom would revert back to the original adhesive. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM INC
MDR Report Key10194586
MDR Text Key196602397
Report NumberMW5095200
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 06/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/24/2020 Patient Sequence Number: 1
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