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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 Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Pain (1994); Rash (2033); Skin Irritation (2076)
Event Date 08/29/2020
Event Type  Injury  
Event Description
Reporter stated she is diabetic and using dexcom g6 glucose monitor. Lately she was experiencing reactions like itching at the 7th day of wearing the sensor when it is supposed to last for 10 days. She said she was having terrible rashes that are weeping, open wound, welt and incredibly painful. She said she normally does not have any reaction to anything and does not have a sensitive skin. She also said since she is diabetic, so any kind of wounds take longer to heal. She had two bad experiences with these sensors. The first time she did not associate it with the sensor. When it happened the second time, she knew that she was having reactions from the sensor.
 
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Brand NameDEXCOM G6 SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10477775
MDR Text Key205319386
Report NumberMW5096365
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
Type of Report Initial
Report Date 08/31/2020
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received08/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
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

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