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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
Lot Number 5279887
Device Problem Loss of or Failure to Bond (1068)
Patient Problems Erythema (1840); Itching Sensation (1943); Swelling (2091); Discharge (2225); Discomfort (2330); Reaction (2414)
Event Date 10/01/2020
Event Type  Injury  
Event Description
Rash / wound; i have been using my dexcom g6 cgm for almost 2 years without any problem. Over the past 2 months and around 6 sensors i have experienced a severe reaction from my sensors. They are designed to last 10 days but i was only making it 6-8 days. While in use the site would become so itchy, it was uncomfortable to wear. The itching then would loosen the adhesive on the edge of the site causing early failure. Then once removed i would have a large sore the exact size of the adhesive patch. The wound would be red, raised, and often ooze. This would last a few days. The oozing would stop but the site remains red, dry, and itchy for weeks. I have attempted to use barrier wipes and flonase to prevent the reaction but so far nothing has worked. I have always used the approved site for the cgm of my abdomen but now have so many bad areas i have had to switch to my arm. This product has changed my life in how controlled my blood sugars have been while wearing them. I would give anything to go back go wearing them comfortably. 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 Key10748498
MDR Text Key213881097
Report NumberMW5097506
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 10/26/2020
6 Devices were Involved in the Event: 1   2   3   4   5   6  
1 Patient was Involved in the Event
Date FDA Received10/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/19/2021
Device Lot Number5279887
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: 10/27/2020 Patient Sequence Number: 1
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