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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 Erythema (1840); Itching Sensation (1943); Pain (1994); Rash (2033); Caustic/Chemical Burns (2549); Blister (4537); Contact Dermatitis (4546)
Event Date 02/01/2021
Event Type  Injury  
Event Description
My daughter is a type 1 diabetic who began using the dexcom continuous glucose monitoring system last year. For the past six months or more she has had serious skin reactions to the sensors, presumably to the adhesive. Symptoms include a serious red, hot rash, including small fluid-filled blisters and breakage of those blisters. The physical appearance is that of chemical burns or severe contact dermatitis. The rash is painful and itching, each spot takes days or weeks to heal, and we fear that there may be long-term scarring on the worst spots. The benefits of the cgm are sufficiently great that we have been seeking solutions from the online diabetic community rather than discontinuing use. We have tried chemical and physical barriers, some of which have provided marginal relief, but even the best of the solutions tried to date still result in some level of painful, raised rash. Fda safety report id # (b)(4).
 
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Brand NameDEXCOM G6 SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11285382
MDR Text Key230703361
Report NumberMW5099231
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 02/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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

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