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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
Model Number G6
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Abrasion (1689); Itching Sensation (1943); Swelling (2091); Discharge (2225); Impaired Healing (2378); Caustic/Chemical Burns (2549)
Event Date 08/12/2020
Event Type  Injury  
Event Description
I have been a user of the dexcom constant glucose monitor to manage type 1 diabetes for years including the g4 and g5 models. Starting about 10 months ago i began using the g6 model. Over years of use of dexcom products i had never had anything more than a mild skin irritation from either adhesive or environmental irritants that were confined to the footprint of the adhesive patch including the beginning of my time with the g6 model. That all changed starting about (b)(6) of 2019. After that time i have had repeated serious skin irritation confined to the shape of the adhesive patch. It looks like a burn injury and not just a mild irritation. I had one person ask me if i fell on the area because it looked like i had sustained a bad abrasion to them. Redness, raised bumps with a yellowish (lymphatic?) discharge and itching has become all too common for me and apparently many other users based on diabetes social media groups that i follow. It takes about 20 days for the injury to heal which includes applying antibiotic ointments and other topical treatments to help with healing. 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 Key10419613
MDR Text Key203489995
Report NumberMW5096094
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 08/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/10/2021
Device Model NumberG6
Device Lot Number5274699
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: 08/17/2020 Patient Sequence Number: 1
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