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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM G6 INTEGRATED CONTINUOUS GLUCOSE MONITORING

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DEXCOM G6 INTEGRATED CONTINUOUS GLUCOSE MONITORING Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Itching Sensation (1943); Peeling (1999); Rash (2033); Reaction (2414); Caustic/Chemical Burns (2549); Skin Burning Sensation (4540)
Event Date 12/31/2020
Event Type  Injury  
Event Description
I was using my dexcom g6 for a couple months prior to the date listed. I had no reactions to my sensors/patch. A few times i had to get a replacement due to the sensor not releasing from its housing. When i used the replacements i had really bad skin reactions. Chemical burns, rashes, raised bumps, itchiness, peeled skin, dry, red and burning skin. I have always used skin tac because i already have sensitive skin. After getting my regularly supplied dexcoms throughout the next couple months i had these reactions. I tried using tegaderm with the skin tac as my doctor suggested. This helped make it through to the 10 day mark that the dexcom normally gets changed at. I was still having pretty bad reactions. I am now using layers of flonase and skin tac to keep the reactions to a minimum but they're still there. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6
Type of DeviceINTEGRATED CONTINUOUS GLUCOSE MONITORING
MDR Report Key11332443
MDR Text Key232220263
Report NumberMW5099391
Device Sequence Number2
Product Code QBJ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/10/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/12/2021
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

Patient Treatment Data
Date Received: 02/12/2021 Patient Sequence Number: 1
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