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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Lot Number 7283079
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Rash (2033); Partial thickness (Second Degree) Burn (2694); Blister (4537)
Event Date 02/22/2021
Event Type  Injury  
Event Description
I have been using the dexcom g6 continuous glucose monitor for about 2 years with no adverse reaction until (b)(6) of 2021. It was very obvious that the adhesive formula had changed which has been verified by dexcom. When removing the sensor it left a red blistering burn and bumpy raised rash that has lasted over 40 days. I have contacted dexcom who said the new formula is causing reactions for many. However, they have not recalled the product or eliminated continuing to use it. I have spoke to both doctors and nurses who are concerned that this reaction could eventually become threatening to the life of the tissue and skin surrounding it. This needs to be investigated i have photos of some of the original rashes and still have current burn marks on my skin from sensors used over 60 days ago. Dexcom (non-medical personnel) suggested using an otc adhesive in addition to their sensor adhesive which seems to be something that would compromise the fidelity of the sensor and the original tests that were used to regulate sensor accuracy and safety. My sister is an rn and said this is considered an extremely severe reaction that should be reported to the fda. Please contact me should you like to obtain pictures of the burns/rashes. Fda safety report id # (b)(4).
 
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Brand NameDEXCOM G6 CONTINUOUS GLUCOSE MONITOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11744424
MDR Text Key248172098
Report NumberMW5101056
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
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/03/2021
Device Lot Number7283079
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

Patient Treatment Data
Date Received: 04/28/2021 Patient Sequence Number: 1
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