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

Lot Number 5281912

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Rash (2033); Reaction (2414)

Event Date 03/14/2021

Event Type  Injury  

Event Description

Since i have type 1 diabetes, i have been using a dexcom g6 continuous glucose monitor (cgm) to measure my blood sugars since (b)(6) of 2018.Before that, i had used previous versions of the dexcom, namely the g4 and g5.In over 6 years of using their products, i had never ever had an issue with their adhesive.In (b)(6) of 2019, dexcom changed the adhesive in the g6.I get my sensors quarterly, so i still had a backstock of sensors with the "old" adhesive.In (b)(6) of 2020, i finally started using the sensors i had gotten in the spring, and i started getting rashes from the adhesive for the first time ever.The one in this report was the very first one on (b)(6) 2020.It looks rather mild compared to those that came afterwards.After a couple of days, i developed some sort of contact dermatitis to an allergen (i still haven't identified the cause) that's causing my hands to itch significantly, and i have rashes and bumps on my hands.This is an ongoing problem that is bothering me and i am convinced that it's not a coincidence that both problems popped up at the same time.Having an allergic reaction to the adhesive means that i had to look for products (patches, bandaids) to put underneath the adhesive.Besides the fact that rashes hurt, it now takes way longer to change my sensor (which i have to do every 10 days) because i have to use additional patches to protect my skin, cut holes in them for the needle to go through, etc.Thousands of other people have the same problems, we post our experiences online, and yet dexcom is still saying that skin reactions aren't a problem.I hope by reporting this, the fda can put pressure on dexcom to change their adhesive to something that doesn't irritate thousands of people at a time.Fda safety report id# (b)(4).

Event Description

Add'l info received from reporter on 02/03/2021 for mw5099205.This is my second report regarding this matter because it has come up multiple times.Please allow me to briefly reiterate the basics: since i have type 1 diabetes, i have been using a dexcom g6 continuous glucose monitor (cgm) to measure my blood sugars since (b)(6) 2018.Before that, i had used previous versions of the dexcom, namely the g4 and g5.In over 6 years of using their products, i had never ever had an issue with their adhesive.In (b)(6) 2019, dexcom changed the adhesive in the g6.I get my sensors quarterly, so i still had a backstock of sensors with the "old" adhesive.In (b)(6) 2020, i finally started using the sensors i had gotten in the spring, and i started getting rashes from the adhesive for the first time ever.The picture in this report relates to the second rash i got because of my dexcom g6.It looks rather mild compared to those that came afterwards.At about the same time, i developed contact dermatitis to an allergen (i still haven't identified the cause) that's causing my hands to itch significantly, and i still have rashes and bumps on my hands.This is an ongoing problem that is bothering me and i am convinced that it's not a coincidence that both problems popped up at the same time.Having an allergic reaction to the adhesive means that i had to look for products (patches, bandaids) to put underneath the adhesive.Besides the fact that rashes hurt, it now takes way longer to change my sensor (which i have to do every 10 days) because i have to use additional patches to protect my skin, cut holes in them for the needle to go through, etc.Thousands of other people have the same problems, we post our experiences online, and yet dexcom is still saying that skin reactions aren't a problem.I hope by reporting this, the fda can put pressure on dexcom to change their adhesive to something that doesn't irritate thousands of people at a time.Fda safety report id# (b)(4).

Event Description

Add'l info received from receiver on 02/03/2021 for mw5099205.This is my third report regarding this matter because it has come up multiple times.Please allow me to briefly reiterate the basics: since i have type 1 diabetes, i have been using a dexcom g6 continuous glucose monitor (cgm) to measure my blood sugars since (b)(6) 2018.Before that, i had used previous versions of the dexcom, namely the g4 and g5.In over 6 years of using their products, i had never ever had an issue with their adhesive.In (b)(6) 2019, dexcom changed the adhesive in the g6.I get my sensors quarterly, so i still had a backstock of sensors with the "old" adhesive.In (b)(6) 2020, i finally started using the sensors i had gotten in the spring, and i started getting rashes from the adhesive for the first time ever.The picture in this report relates to the third rash i got because of my dexcom g6, which i tried to prevent by attaching a patch underneath the adhesive, however i still got a rash.You can also see an old rash that still hadn't cleared up by that point.Subsequent rashes were more severe.At about the same time, i developed contact dermatitis to an allergen (i still haven't identified the cause) that's causing my hands to itch significantly, and i still have rashes and bumps on my hands.This is an ongoing problem that is bothering me and i am convinced that it's not a coincidence that both problems popped up at the same time.Having an allergic reaction to the adhesive means that i had to look for products (patches, bandaids) to put underneath the adhesive.Besides the fact that rashes hurt, it now takes way longer to change my sensor (which i have to do every 10 days) because i have to use additional patches to protect my skin, cut holes in them for the needle to go through, etc.Thousands of other people have the same problems, we post our experiences online, and yet dexcom is still saying that skin reactions aren't a problem.I hope by reporting this, the fda can put pressure on dexcom to change their adhesive to something that doesn't irritate thousands of people at a time.Fda safety report id# (b)(4).

Event Description

Add'l info received from reporter for mw5099205 on 02/03/2021.This is my fifth report regarding this matter because it has come up multiple times.Please allow me to briefly reiterate the basics: since i have type 1 diabetes, i have been using a dexcom g6 continuous glucose monitor (cgm) to measure my blood sugars since (b)(6) 2018.Before that, i had used previous versions of the dexcom, namely the g4 and g5.In over 6 years of using their products, i had never ever had an issue with their adhesive.In (b)(6) 2019, dexcom changed the adhesive in the g6.I get my sensors quarterly, so i still had a backstock of sensors with the "old" adhesive.In (b)(6) 2020, i finally started using the sensors i had gotten in the spring, and i started getting rashes from the adhesive for the first time ever.The picture in this report relates to the fifth and most severe rash i got because of my dexcom g6.At about the same time, i developed contact dermatitis to an allergen (i still haven't identified the cause) that's causing my hands to itch significantly, and i still have rashes and bumps on my hands.This is an ongoing problem that is bothering me and i am convinced that it's not a coincidence that both problems popped up at the same time.Having an allergic reaction to the adhesive means that i had to look for products (patches, bandaids) to put underneath the adhesive.Besides the fact that rashes hurt, it now takes way longer to change my sensor (which i have to do every 10 days) because i have to use additional patches to protect my skin, cut holes in them for the needle to go through, etc.Thousands of other people have the same problems, we post our experiences online, and yet dexcom is still saying that skin reactions aren't a problem.I hope by reporting this, the fda can put pressure on dexcom to change their adhesive to something that doesn't irritate thousands of people at a time.Fda safety report id# (b)(4).

Event Description

This is my forth report regarding this matter because it has come up multiple times.Please allow me to briefly reiterate the basics: since i have type 1 diabetes, i have been using a dexcom g6 continuous glucose monitor (cgm) to measure my blood sugars since (b)(6) 2018.Before that, i had used previous versions of the dexcom, namely the g4 and g5.In over 6 years of using their products, i had never ever had an issue with their adhesive.In (b)(6) 2019, dexcom changed the adhesive in the g6.I get my sensors quarterly, so i still had a backstock of sensors with the "old" adhesive.In (b)(6) 2020, i finally started using the sensors i had gotten in the spring, and i started getting rashes from the adhesive for the first time ever.The picture in this report relates to the forth rash i got because of my dexcom g6.You can also see an old rash that still hadn't cleared up by that point.Subsequent rashes were more severe.At about the same time, i developed contact dermatitis to an allergen (i still haven't identified the cause) that's causing my hands to itch significantly, and i still have rashes and bumps on my hands.This is an ongoing problem that is bothering me and i am convinced that it's not a coincidence that both problems popped up at the same time.Having an allergic reaction to the adhesive means that i had to look for products (patches, bandaids) to put underneath the adhesive.Besides the fact that rashes hurt, it now takes way longer to change my sensor (which i have to do every 10 days) because i have to use additional patches to protect my skin, cut holes in them for the needle to go through, etc.Thousands of other people have the same problems, we post our experiences online, and yet dexcom is still saying that skin reactions aren't a problem.I hope by reporting this, the fda can put pressure on dexcom to change their adhesive to something that doesn't irritate thousands of people at a time.Fda safety report id# (b)(4).

Event Description

Additional information received from reporter on (b)(6) 2021 for mw5099205.In order to manage my type 1 diabetes, i use the dexcom, a continuous glucose monitor.I've been using products from dexcom for 7 years without having any bad reactions to their adhesive.In (b)(6) of 2020, i started getting severe rashes from the adhesive on the dexcom.Several weeks later i found out that the adhesive had been changed in (b)(6) 2019.I reported all my rashes to dexcom as well as the fda and started using a physical barrier to protect my skin.In (b)(6) 2021 i tried out a new barrier underneath the sensor, but it wasn't strong enough to block dexcom's irritating substance, resulting in yet another rash.Even after treating it with cortisone cream, i can still see the rash 3 weeks later.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11273887
• MDR Text Key: 230111245
• Report Number: MW5099205
• Device Sequence Number: 1
• Product Code: MDS
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 5281912
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/03/2021; 02/03/2021; 02/03/2021; 02/03/2021; 04/05/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: MALTOFER (IRON SUPPLEMENT); NOVORAPID (INSULIN); OMNIPOD (INSULIN PUMP)
• Patient Outcome(s): Other
• Patient Age: 24 YR
• Patient Weight: 56