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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
Device Problem Product Quality Problem (1506)
Patient Problems Inflammation (1932); Itching Sensation (1943); Scar Tissue (2060); Discharge (2225); Reaction (2414)
Event Type  Injury  
Event Description
I have type 1 diabetes and rely on a continuous glucose monitor (cgm). I have been using dexcom cgm for half a year without any problems. Starting this summer, my skin has been inflamed, itchy, scarred, and producing pus only at the site at which i insert the cgm sensor. Although the sensor is approved for 10 days of use on our skin, i can feel my skin reacting to it in less than 24 hours and takes at least a month for my skin to fully heal even if i have the sensor on my skin for 1 day. I have tried the recommended work arounds to it such as using allergy medication at the site of sensor insertion, but it does not help. I have not had any problems with dexcom sensors before i switched, and also do not have any issues with the adhesive that is being used for an insulin pump that stays on my skin for 3 days. Timing of my severe skin reaction to the dexcom sensor lines up with around when they acknowledged a change in their adhesive formulation for the sensors. Dexcom stated the adhesive change was to ensure that the sensor would stay on our skin for 10 full days, but that problem was something that could be addressed by the use of medical tape. The adhesive is also now unnecessarily strong that i struggle to get it off without tearing up my skin. 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 Key10903003
MDR Text Key218701845
Report NumberMW5098063
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 11/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
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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