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U.S. Department of Health and Human Services

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

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DEXCOM, INC. G6 SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Lot Number 5278420
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Rash (2033)
Event Date 12/28/2020
Event Type  Injury  
Event Description
I am a long time user of the dexcom g6 continuous glucose monitor. I use this product to help manage my type one diabetes. In august, i noticed a rash develop underneath my skin below the dexcom. This was not normal, so i attributed it to being a faulty unit or a mistake on my part. Since august, i have developed a rash from every dexcom g6 cgm i have used. I have contacted dexcom with the issue, and they are refusing to help customers with this issue. There is currently a (b)(6) petition with nearly 5000 signatures ((b)(6)) asking dexcom to change the adhesive. The rashes developed from the product ooze pus and last for over a week after the product is removed. Thousands of users experience this issue from normal use of the dexcom g6 cgm, and dexcom is offering no recourse except for replacing the product with a new one that will create the same rash, and they refuse to change the adhesive. Fda safety report id# (b)(4).
 
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Brand NameG6 SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11100401
MDR Text Key224810350
Report NumberMW5098583
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 12/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/22/2021
Device Lot Number5278420
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

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