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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITOR SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number G6
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Pain (1994); Rash (2033); Scarring (2061); Skin Irritation (2076)
Event Date 06/25/2020
Event Type  Injury  
Event Description
Dexcom g6 continuous glucose monitor sensors caused skin irritation, rash and possible scarring due to what seems to be a reaction to their new stronger adhesive formula. I have red blistered patches where the last four sensors were located, most recently on my arm where i was forced to remove it early due to itching and pain. Patches of irritation on my abdomen from the last six weeks have not healed. Like many, many other users i had no problem with the old formulation, and apparently the company changed their adhesive early this year without warning, and thousands of users around the world are having similar and worse reactions. Patient is an athlete and in excellent health. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6 CONTINUOUS GLUCOSE MONITOR SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10223905
MDR Text Key197596326
Report NumberMW5095334
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 06/29/2020
4 Devices were Involved in the Event: 1   2   3   4  
0 Patients were Involved in the Event:
Date FDA Received07/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Model NumberG6
Device Lot Number5271313
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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