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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 SENSOR, GLUCOSE, INVASIVE

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DEXCOM, INC. DEXCOM G6 SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number 5275431
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Rash (2033); Skin Irritation (2076)
Event Date 09/21/2020
Event Type  Injury  
Event Description
I have been a long time user of dexcom continous glucose monitoring. Since the summer i have noticed a sudden onset rash and extreme skin irritation. In speaking with dexcom they admitted there was a change to their adhesive formula and admitted they were seeing many calls on this topic but had no plans to revert back to the previous adhesive. The issue is that the dexcom is worn for 10 days, for me, the itching begins within a day of insertion, and by the time the dexcom sensor is changed their severe skin damage. As a diabetic, any form of a wound is of concern and these dexcom sensor welts are taking 4-6 weeks to heal. These sensors are worn on the abdomen so in a rotation of locations you eventually need to use an insertion site that is not fully healed. I fear there will be scaring due to this change in the adhesive. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10573913
MDR Text Key208359631
Report NumberMW5096818
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 09/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/01/2021
Device Model Number5275431
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/22/2020 Patient Sequence Number: 1
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