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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 CGM SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Rash (2033); Skin Irritation (2076)
Event Date 03/01/2020
Event Type  Injury  
Event Description
I have been using dexcom cgm for over a year. This past (b)(6) i started getting very bad rashes from the cgm sensors. The rashes develop scabbing and you can clearly see the outline of the sensor and sensor components in the affected area. I read online that they changed the adhesive on the sensor in december 2019. I never had a rash from one of these until (b)(6) 2020. It has gotten so bad that i typically can only leave a sensor on for 3-5 days of the 10 days these sensors are fda approved for. The last one that i just removed was only used approx 28 hours before the itching got to be too much to take. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6 CGM
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10319834
MDR Text Key200451682
Report NumberMW5095695
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 07/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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?
Type of Device Usage

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