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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE METER SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number G6 SENSOR
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033); Skin Inflammation/ Irritation (4545)
Event Date 12/02/2020
Event Type  Injury  
Event Description
Itchy, painful rash; i started using the dexcom g6 cgm in (b)(6) 2020. It stays on your skin for 10 days, after that time you remove it and replace it with a new one on a different site on your body. Never had any skin issues with it. Starting in (b)(6) 2020, i noticed after 1-2 days of insertion, that the skin under the device started to itch. It was itching all the time, until i finally took it off after 10 days. After removal, i was shocked how horribly my skin looked. It was blotchy, red patches, in the exact shape of the dexcom's adhesive. It took several weeks until it was finally better and was not itchy any more. I don't know if dexcom changed the formula for their adhesive, but i never had a reaction the first 2 months. I now put a piece of tegaderm skin patch between my skin and the dexcom cgm, but it still irritates my skin tremendously. I really value the convenience of the cgm and how helpful it is with my diabetes control, but the itching is almost unbearable. Fda safety report id # (b)(4).
 
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Brand NameDEXCOM G6 CONTINUOUS GLUCOSE METER SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11553002
MDR Text Key242062641
Report NumberMW5100175
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 03/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/12/2021
Device Model NumberG6 SENSOR
Device Catalogue NumberREF STS-OE-003
Device Lot Number7282151
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: 03/22/2021 Patient Sequence Number: 1
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