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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 GLUCOSE SENSOR SENSOR, GLUCOSE, INVASVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Rash (2033); Discharge (2225); Reaction (2414); Caustic/Chemical Burns (2549); Blister (4537)
Event Date 02/10/2021
Event Type  Injury  
Event Description
I have been using the dexcom g6 for 2 years. I have greatly improved control of my diabetes while using it and depend on readings to manage my type 1 diabetes. In the last 8 months i have been experiencing an allergy to the adhesive on the sensor/ my skin starts to blister and ooze until i have to remove the sensor. I went to an allergist and he reported that it was due to the acrylic used in the adhesive. I reported this to dexcom last year. While dexcom replaces the sensor, the sensor requires a 2 hour warm-up every time it needs to be changed. I am not getting 10 days use from the sensor which is widely advertised. I also am running out of places to attach due to scarring from the rashes. When i call dexcom some of the representatives say they have never heard of the issue i am having, others state that they are aware and working on it and it is due to changing the adhesive. I have had instances of very high blood glucose levels and very low levels while having to wait for the sensor to warm-up. This is no longer a minor issue but a functional issue for how the product was designed to work. When it isn't causing my skin to have chemical burns this is a very valuable product. I have also followed all of the recommendations that dexcom has posted to try to prevent the reaction. None of them have worked in my case. I have also been told that the adhesive was changed to ensure that the sensor stays on for the full 10 days. My recommendation is that dexcom go back to the original adhesive and have two types of sensors, one that is less allergenic and my fall off without and additional overlay from another supplier and one that is super adhesive that may cause chemical allergic burns. This product should be required to have a warning similar to what is found on cosmetics that it can cause an allergic reaction and to contact your healthcare professional if this occurs. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6 GLUCOSE SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11332291
MDR Text Key232222883
Report NumberMW5099387
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 02/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
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: 02/12/2021 Patient Sequence Number: 1
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