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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 CGM SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Pain (1994); Swelling/ Edema (4577)
Event Date 10/05/2021
Event Type  Injury  
Event Description
I'm a long time type 1 diabetic and use the dexcom g6 sensor paired to a tandem insulin pump. Dexcom changed its adhesive used to hold the g6 sensor in place. Since at least a year ago i have redness and swelling under the sensor whenever i pull the old ones off. It is uncomfortable and even painful at times. Dexcom has known about it for a long time, says it is a common skin allergic reaction, but has taken no measures to change the formula of the adhesive. A very great number of users have the same problem and talk about it on diabetic social sites like (b)(6). I can send you the latest expired sensor if you want one, or a brand new one.
 
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Brand NameDEXCOM G6 CGM SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key12624114
MDR Text Key276370959
Report NumberMW5104547
Device Sequence Number1
Product Code MDS
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
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: 10/12/2021 Patient Sequence Number: 1
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