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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 CGM SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number 9500-45
Device Problem Product Quality Problem (1506)
Patient Problems Itching Sensation (1943); Skin Discoloration (2074); Skin Irritation (2076)
Event Date 08/19/2020
Event Type  Injury  
Event Description
Hello my name is (b)(6) i am a dexcom g6 cgm user. I have to insert a sensor patch on my skin every 10 days to monitor my blood sugar levels. In the past i have had no problems until recently. The last 2 sensors i have installed have left an oval shape burn or bad skin irritation mark on my skin. I had researched it, and apparently dexcom has changed the adhesive used on the sensor patch. What i feel is my the sensor area itches first then a red ring appears around the patch area. Generally you apply the patch around the abdomen area. Currently i have 2 sites on my abdomen area that are affected. I have pictures of both patch areas. And a picture of the packaging. The 1st patch area i have been putting burn ointment on it. I believe there will be permanent scars. I had older sensors which i installed yesterday (b)(6) 2020 so far i have noticed any irritation yet. I do know they switched adhesives on dexcom g6 cgm sensor patch, so i'm hoping this older version will not give me a burn. If you have any questions you can contact me at (b)(6). Thank you (b)(6). Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6 CGM
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10514364
MDR Text Key206566408
Report NumberMW5096522
Device Sequence Number2
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 09/08/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received09/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9500-45
Device Catalogue Number9500-45
Device Lot Number7268142
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: 09/09/2020 Patient Sequence Number: 1
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