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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Scarring (2061); Burning Sensation (2146); Reaction (2414); Blister (4537)

Event Date 10/22/2020

Event Type  Injury  

Event Description

I am a type 1 diabetic and it was recommended by my endocrinologist to start wearing a continuing glucose monitor (cgm) due to having multiple hypoglycemic unawareness episodes.I was recently approved and started using the dexcom g6 cgm in (b)(6) 2020.The first box of 3 sensors i wore, in (b)(6) 2020, were fine and caused me no problems; however, once i started with the second box a month later in (b)(6) 2020, i began to have an adverse reaction to the adhesive used on the dexcom g6 sensor.This reaction has caused severe skin issues, including redness, extreme itchiness, burning, blistering, and scarring.My sensors only lasted about 4 days, when they are intended to last 10 days, and they fell off due to the blisters oozing underneath the sensor.I have contacted dexcom multiple times, spoke with a customer service technician and a nurse who only recommended using flonase, skin tack and an overpatch.They sent me two replacement sensors and sent me a 10 pack of the overpatchs.I have now attempted the following, paying out of pocket for these items to address this issue: flonase and skin tack (failed), flonase, skin tack, and overpatch (failed), flonase, skin tack, tegaderm, and overpatch (failed).There are multiple complaints regarding this exact issue on social media and on my diabetic support group.Dexcom is aware of this issue and only stated that it is less than 1% of users having this problem.This excuse to not address this issue is ludicrous.Dexcom is my only option for a cgm as my insurance plan does not cover the freestyle equipment.Seeing how many users are complaining about this issue and how it seems to just have begun in early 2020 due to an adhesive change on dexcom's part, i find it hard to believe that only 1% of users are having this problem.Either way, dexcom needs to revert to the adhesive they were using prior to these issues or make available another sensor adhesive option for users who are having this problem.Telling users who are having not only a bad reaction but scarring due to this change, which has also now effected insulin injection and pump sites, that we are just 1% and that they have no intention of addressing this issue is not ok.I have tried and failed to address this issue myself directly with dexcom and now request that the fda please get involved with helping not only myself, but all current and future users of dexcom g6 who are and will have similar issues.Thank you.Fda safety report id # (b)(4).

• Brand Name: SENSORS
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11195262
• MDR Text Key: 228016626
• Report Number: MW5098870
• Device Sequence Number: 3
• 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: 01/14/2021
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• 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): Other
• Patient Age: 36 YR
• Patient Weight: 50