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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Rash (2033); Scar Tissue (2060); Discomfort (2330); Skin Inflammation/ Irritation (4545)

Event Date 06/06/2021

Event Type  Injury  

Event Description

This has happened multiple times, with today being the most recent.I have horrible reactions to the adhesive of the dexcom continuous glucose monitor.They changed the adhesive a while ago and myself and countless other diabetics have had horrible reactions.The adhesive makes my skin so itchy and painful i can't wear it the full ten days.Last night, and one other time, i have been awakened by pain from the sensor and couldn't fall back asleep till i ripped it out.I've done a lot of trouble shooting and the only thing that helps is wearing an expensive hydrocolloid patch under it.Unfortunately i still have some irritation with that, it's just more mild, and the patch is so thick that the sensor still doesn't last the full ten days.I have scarring from just over a year ago from a bad reaction to dexcom adhesive.I have contacted the company as well as the better business bureau because i am so sick of having to rely on a piece of medical technology that causes me harm and discomfort.Many diabetics i've found through (b)(6) have had the same problems as me and dexcom refuses to change the adhesive back to the old one.It is so horrible to deal with painful rashes that look like chemical burns.They take over a month to heal and leave scars.They are incredibly painful to the point where it distracts me from going about my day as normal.I am including photos of some of the reactions i've had.Lantus in case insulin pump breaks and need long acting insulin (never needed) basqimi in case of severe low blood sugar (never needed).Fda safety report id# (b)(4).

• Brand Name: SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11965970
• MDR Text Key: 256323903
• Report Number: MW5101773
• 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: 06/06/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• 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: 22 YR
• Patient Weight: 66