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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
Model Number G6
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Rash (2033)
Event Date 01/01/2021
Event Type  Injury  
Event Description
I am a diabetic and i use dexcom g6 to test my blood sugar. I have used dexcom cgm for five years, and their products have worked well for me. However, for the last month every sensor i have applied to myself has given me a painful rash. I called dexcom and they said that they changed the formula of the glue they are using and are getting many complaints of painful rashes from there sensors. Now i have to put a tape and band-aid barrier between myself and the sensor to continue cgm. I think the chemicals in dexcoms glue is toxic. 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 Key11261039
MDR Text Key230111795
Report NumberMW5099114
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 01/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG6
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: 01/29/2021 Patient Sequence Number: 1
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