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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Itching Sensation (1943); Skin Irritation (2076); Swelling (2091); Reaction (2414)
Event Date 04/01/2020
Event Type  Injury  
Event Description
I have been wearing a dexcom g6 glucose sensor for years. I have never had any skin problems with the adhesive until about a couple of months ago. Around that time i started getting skin reactions around the dexcom sensor site. The reaction was itchy skin, redness of skin under the adhesive and red irritated red bumps under the adhesive site as well. The last skin reaction was severe and i had to go to the doctor for treatment. I called the dexcom company and was told they recently changed the adhesive as they were having problems with the adhesive not adhering to the skin. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10178968
MDR Text Key196136395
Report NumberMW5095105
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 06/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/19/2020 Patient Sequence Number: 1
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