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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cellulitis (1768); Hypersensitivity/Allergic reaction (1907); Skin Irritation (2076)
Event Date 08/06/2020
Event Type  Injury  
Event Description
I have pictures if needed. (b)(6) diabetic that cannot wear sensor anymore as it causes a horrible allergic reaction on her skin. Sometimes resulting in cellulitis. The reaction will be around the sensor and will end up pushing and will carry down her whole arm. The company said they've changed their adhesive recently. This is a new symptom that has not always been there. Started with the change of adhesive. It's affected her to the point that despite trying multiple barriers, she's not able to wear it. This is a device that makes life easier for her. It "talks" to her insulin pump that then will make adjustments as needed. It helps keep her a1c at bay. It's devastating she's not able to make it work just because the company changed the adhesive. Continuous glucose monitor: dexcom g6 product should last 10 days, after 2 days it causes the horrible reaction. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10396201
MDR Text Key202760463
Report NumberMW5096024
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 Family Member or Friend
Type of Report Initial
Report Date 08/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
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: 08/11/2020 Patient Sequence Number: 1
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