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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 DEXCOM G6 SENSOR
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Rash (2033); Urticaria (2278); Reaction (2414); Skin Burning Sensation (4540)
Event Date 01/23/2021
Event Type  Injury  
Event Description
Starting in (b)(6) 2020 i have had repeated allergic rashes to dexcom's g6 sensors. I have worn dexcom sensors for years and the g6 since it's release and have never experienced the reactions i am currently experiencing (most recently on (b)(6) 2021). The sensors (i believe the adhesive specifically) is causing a pink urticaria type rash under and around where it is attached. The rash is itchy and burns intensely and appears with 24 hours of insertion and worsens until i remove the sensor. I have had to remove several at day 2 or 3 despite them being approved for 10 day wear. Initially i used only alcohol swabs to prep the insertion sites but since the rashes began i have tried: skin tac, safe and simple barrier wipes, cavilion wipes, mastisol, tegaderm, iv 3000, and duo derm hydrocolloidal dressings. I also applied topical cortisone ointment and cream, fluctisone nasal spray on the skin and topical diphenhydramine. The hydrocolloidal dressing with diphenhydramine spray seems to allow me the best chance to get 10days wear from the sensor. 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 Key11278889
MDR Text Key230535593
Report NumberMW5099220
Device Sequence Number1
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 02/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2021
Device Model NumberDEXCOM G6 SENSOR
Device Catalogue Number9500-45
Device Lot Number5275658
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

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