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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Device Ingredient or Reagent Problem (2910)
Patient Problems Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)
Event Date 05/01/2020
Event Type  Injury  
Event Description
Patient called to report an adverse reaction to his dexcom g6 sensor. Patient stated he's been using the device for over a year with no issues, but about a year ago he noticed a change with the adhesive. Patient stated he thinks dexcom must have changed the chemical composition of the sensor adhesive because after 3 days of wearing the sensor he experiences severe burning sensation at the site. Patient stated that the sensors are meant to be worn for up to 10 days, but after only 3 days he gets a very bad skin reaction. Patient stated he's called dexcom several times and has talked to representatives and nurses who have been helpful and provided him with different barriers he could try to use between the skin and the sensor to help lessen the skin irritation and burning. Patient stated these barriers did help for a while, but now they aren't working as well, and he's noticed his skin reactions are getting worse.
 
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Brand NameDEXCOM G6 SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11806380
MDR Text Key250295087
Report NumberMW5101283
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 05/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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: 05/10/2021 Patient Sequence Number: 1
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