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U.S. Department of Health and Human Services

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

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DEXCOM, INC. G6 CONTINUOUS GLUCOSE MONITORING DEVISE SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number G6
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Irritation (1941); Itching Sensation (1943); Peeling (1999); Rash (2033); Scar Tissue (2060); Swelling (2091); Skin Inflammation (2443)
Event Date 04/20/2020
Event Type  Injury  
Event Description
I have been using dexcom continuous glucose monitoring (cgm) devices consistently for 2+ years. However, my latest shipment of dexcom g6 devices have caused severe skin irritations, rashes, and dermatitis. After applying the product adhesive to my skin site, the site becomes extremely itchy and swollen within hours. The product is meant to last 10 days on my skin before i have to swap it out. However, with this latest batch, i am unable to get through even a day or two. I tried other sensors from the shipment to make sure it was not just one bad sensor, and unfortunately, they are all causing the same adverse reaction. In order to maintain strict monitoring of my blood sugar, i tried to use allergy ointments and continue using the cgm device for a few days at a time, but experienced severe skin burning, itching, peeling, and redness. I consulted with my endocrinologist and was advised to use a steroid nasal spray on the skin to prevent skin rashes, but this did not help. I am currently unable to use the dexcom product due to sever skin rash that look like chemical burns. I have looked online and there are hundreds of users who are posting and reporting the same side effects from dexcom's g6 sensors on social media forums. Hundreds are posting pictures on social media and are encouraging one another to contact the fda to step in and protect consumers from the effects of the new faulty adhesive on the dexcom g6 continuous glucose monitoring device. Based on consumer comments, it seems that dexcom changed their adhesive formula in (b)(6) 2020. The company has gone as far as to delete posts detailing the negative side effects from its social media platforms to hide this issue. I know several individuals who have posted pictures of their rashes and to later find their comments deleted on dexcom's official (b)(6) page. When i reached out to dexcom directly, i was instructed to call my endocrinologist and that likely have sensitive skin. Dexcom did not provide me any support on how to remedy this issue. Diabetics, but nature heal slowly and scars/burns take much longer to treat. At this point i have not used the product for more than 3 weeks, yet have red and burnt scars all over my arms and abdomen that will likely take 4-5 months to fully heal. As a diabetic, i inject insulin via syringes 6-8 times a day. Due to the scarring, i am unable to inject insulin on those sites and not have limited options. In summary, the new adhesive sticker on the dexcom continuous glucose monitoring devise has caused skin irritation, rashes, and burns. Fda safety report id #: (b)(4).
 
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Brand NameG6 CONTINUOUS GLUCOSE MONITORING DEVISE
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10104947
MDR Text Key194030289
Report NumberMW5094759
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 05/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG6
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: 05/29/2020 Patient Sequence Number: 1
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