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U.S. Department of Health and Human Services

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

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DEXCOM, INC. SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
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).
 
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Brand NameSENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11965970
MDR Text Key256323903
Report NumberMW5101773
Device Sequence Number2
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
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 Received06/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
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: 06/08/2021 Patient Sequence Number: 1
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