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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
Model Number G6
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033)
Event Date 06/01/2020
Event Type  Injury  
Event Description
My (b)(6) year old daughter wears a dexcom g6 continuous glucose monitor for her type 1 diabetes. These devices require inserting a sensor into the skin and the sensor is held in place with an adhesive patch that's connected to the sensor. Around the beginning of summer 2020, with a new delivery of sensors from dexcom, my daughter started having a serious adverse reaction to the adhesive on the sensors. It creates a bright red itchy and weeping welt on her arm in the exact shape of the sensor patch. We also had to take the sensors off early as they were itching too bad. I saw posts on a diabetes (b)(6) page of others having the same problem and they noted dexcom had changed their adhesive. Reading that i called and reported it to dexcom. The rep i spoke to confirmed they had changed their adhesive and they were aware of the problem. We continue to get these sensors that cause the same problem and have had to start buying duoderm patches to wear under the dexcom. However, i need to cut a hole in that patch for the sensor to insert through and my daughter still gets a red welt where that cut out is located. So i know dexcom hasn't fixed the problem. This worries me that whatever is in the new adhesive could also be leaching into her skin, either just through contact or through the sensor insertion site or through the raw welt that the adhesive is creating. My daughter's endocrinologist has also had to prescribe a steroid cream to put on these welts to help them heal. 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 Key10829088
MDR Text Key216191162
Report NumberMW5097787
Device Sequence Number1
Product Code MDS
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 11/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/10/2021
Device Model NumberG6
Device Catalogue Number9500-45
Device Lot Number5276195
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: 11/10/2020 Patient Sequence Number: 1
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