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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
Lot Number 5275655
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Burn(s) (1757); Skin Irritation (2076); Blister (4537)
Event Date 10/07/2020
Event Type  Injury  
Event Description
I have been using the dexcom g6 sensors to monitor my blood glucose since (b)(6) 2020. In the past month, i have been experiencing burns at the application sites. The burns consist of tiny blisters that begin to weep. The irritation has caused hyper pigmented areas to where the sensors have been placed. When i reported it to my insurance company, i was given the following link: (b)(6). I have tried to use some of the recommendations; however, none of them have worked. I attempted to contact dexcom directly at (b)(6) and was told that they did change the formula for the adhesive in (b)(6) 2019. They were not able to provide an actual solution to prevent this from happening again. From researching this matter online, i have been able to see that i am not the only consumer to report this problem to dexcom or the fda. 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 Key10670025
MDR Text Key211309564
Report NumberMW5097194
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 10/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/29/2021
Device Lot Number5275655
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

Patient Treatment Data
Date Received: 10/09/2020 Patient Sequence Number: 1
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