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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 REF STS-OE-003
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hyperglycemia (1905); Discharge (2225); Impaired Healing (2378); Reaction (2414)
Event Date 04/20/2020
Event Type  Injury  
Event Description
Started a new box of dexcom sensors and experienced what appeared as a burn. Three total sensors were used, the last only could be worn 3 out of 10 days. Reported to dexcom and the replaced with a new sensor. Dexcom sent an email stating that they had changed the adhesive formula but not communicated to their customers. I have experienced blistered, raw skin that will not heal. The last wound wept for 2 days and i experienced high blood sugars for over 24 hours. There are a total of three wounds that have not healed since april 20. Applied a barrier between skin and device and testing now, but i have used this product since 2016 with no issues until this point. 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 Key10061168
MDR Text Key191253032
Report NumberMW5094504
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/13/2020
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received05/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/08/2021
Device Model NumberREF STS-OE-003
Device Catalogue NumberNDC 08627-0053-03
Device Lot Number5268278
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: 05/14/2020 Patient Sequence Number: 1
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