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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM SENSOR, GLUCOSE, INVASIVE

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DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number G6
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Local Reaction (2035); Scarring (2061); Burning Sensation (2146)
Event Date 11/22/2020
Event Type  Injury  
Event Description
Extreme allergic reaction; while using the dexcom g6 continuous glucose monitoring (cgm) system, i had a very bad allergic reaction to what i believe was the adhesive on the sensor. The adhesive caused almost what looked like a burn on my skin where the sensor patch was located. The sensors are supposed to be worn for 10 days, but i had to remove after 7 due to severe itching and burning. After approximately three weeks the mark left by the reaction to the sensor is still very visible on my arm. I have been using this cgm system for over a year and the past two sensors that i have used have caused the same side effect. This reaction has never happened before these last two sensors. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6 CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11010334
MDR Text Key221517266
Report NumberMW5098330
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 12/09/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG6
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: 12/11/2020 Patient Sequence Number: 1
Treatment
ATORVASTATIN; HUMALOG INSULIN; TIMOLOL; TOUJEO INSULIN
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