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

Device Problems Patient-Device Incompatibility (2682); Device Ingredient or Reagent Problem (2910)

Patient Problems Purulent Discharge (1812); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Urticaria (2278); Skin Inflammation/ Irritation (4545)

Event Date 02/01/2020

Event Type  Injury  

Event Description

I am type 1 diabetic and i have been using the dexcom cgm system since 2013.I have had no prior allergy to any adhesive ever placed on my body in my life.All of a sudden, at the (b)(6) of 2020 i started noticing my dexcom sites becoming increasingly more irritating.I experienced a terrible itching sensation under my sensor so bad that it would keep me up at night.I would try my hardest not to tear the sensor clean off as they are quite expensive, so i waited until the 10 days were up (change every 10 days per dexcom).After taking off the sensor i would experience so much relief but found a huge, bubbly, pusing, itchy, vibrant red wound under the adhesive.In the perfect shape of the dexcom.I tried switching locations but it continued to the point where i couldn't wear it for 2 hours.I then found some relief by placing a barrier between the sensor and my skin and that's what i've been doing ever since.However, even with the barrier, i'm experiencing hives and itching sensations now around the perimeter the sensor.I've thought about switching brands of cgm but i have a t-slim tandem insulin pump that works together with my dexcom to deliver insulin throughout the day (smart iq).I've paid (b)(6) dollars for these devices and i can't afford to switch my entire system.I've contacted dexcom multiple times and they are aware of these issues, i get the same "we switched back in blah blah, we're sorry, here's a replacement".I'm still allergic to this device and i'm certainly not alone.My mother, who is also type 1 diabetic, has also been using dexcom for years.After taking a break and coming back to it in 2021, she now has the exact same allergic reaction that i and so many others are facing.I have never struggled with eczema in my life but after using dexcom and having these reactions over the past nearly year and a half, has lead to triggering eczema flare ups where 2 month old sensor spots have been.This issue needs reported to the fda.There's thousands and thousands of us dealing with this giant mistake made by dexcom.Fda safety report id# (b)(4).

• Brand Name: SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 12576367
• MDR Text Key: 274957253
• Report Number: MW5104378
• Device Sequence Number: 2
• Product Code: MDS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/30/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR
• Patient Weight: 61