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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Lot Number 5271848
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Rash (2033); Skin Irritation (2076); Reaction (2414); Skin Inflammation (2443); Fluid Discharge (2686)
Event Date 07/18/2020
Event Type  Injury  
Event Description
I am a type 1 diabetic. I have been using a dexcom g6 continuous glucose monitor for blood sugar management since (b)(6) 2019. Before (b)(6) 2020, i had great success with the product. However, i was informed by a dexcom representative that they recently made changes to the adhesive formula that they use on their sensor devices. I got a new shipment of sensors in early (b)(6) 2020. I have used four sensors from the new shipment since that time. Each sensor is supposed to stay attached to the skin of the abdomen for ten days at a time. However, i have had problems keeping the new sensors attached and three of the four detached early after only five to nine days. This was not an issue before receiving this new shipment. More importantly, over the course of using the four sensors, i have been left with an increasingly severe rash at the sensor placement site. I do not use the same placement location for each new sensor, i rotate the placement around my abdomen. It has become so severe that after the fourth sensor fell off after only six days, i was left with a large, itchy, inflamed, red rash on my abdomen with my skin broken open and seeping fluids. I have several sensors left, but i have had to discontinue use of the sensors altogether because i fear i am now risking infection. When i called dexcom, they only offered to replace the sensors that fell off early. However, that is of little use to me because i can not use the replacement sensors if they are going to continue to cause such a terrible reaction. Online research has shown me that many, many people are having similar problems with very severe reactions to this irritation. Dexcom told me they are aware of the issues. I have relied on this device for maintain my health and sustain my life. They have not provided any explanation for the changes to their adhesive formula that is causing a significant reduction to many people's quality of life. I have attached an image of the dexcom packaging, as well as the skin reaction i experienced to the third sensor discussed above. My skin's reaction to the fourth sensor was actually when the wound broke the skin and started seeping, but i did not take a picture of it. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6 SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10338288
MDR Text Key201055985
Report NumberMW5095775
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/25/2020
4 Devices were Involved in the Event: 1   2   3   4  
1 Patient was Involved in the Event
Date FDA Received07/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2021
Device Lot Number5271848
Was Device Available for Evaluation? Yes
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: 07/28/2020 Patient Sequence Number: 1
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