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U.S. Department of Health and Human Services

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

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DEXCOM, INC. SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Rash (2033); Reaction (2414)
Event Date 06/01/2020
Event Type  Injury  
Event Description
I use the dexcom 6 glucose device and the sensor that i attach to my skin breaks it out severely. I started using this product in (b)(6) 2020 and did not any issues. It came with a 3 month supply, but when i reordered that is when i started having the problem. I have notified dexcom about the problem. They have called me buy that does not help with my skin breaking out. I have done research on the inter net i notice other people having the same problems. They call it the dexcom rash. I have tried barrier tape, barrier wipes, spraying flonase on the spot where i attach the dexcom sensor. The concept is good but it has to be something that can be done for us people that break out. I saw a internet post that said that i should contact the fda and tell them about my problem. I do not know what you can do, but i wanted to make you aware of what is happening with the dexcom 6 sensors. Fda safety report id# (b)(4).
 
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Brand NameSENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11332486
MDR Text Key232220688
Report NumberMW5099392
Device Sequence Number2
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 02/11/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/12/2021
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

Patient Treatment Data
Date Received: 02/12/2021 Patient Sequence Number: 1
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