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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 CGM SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number G6 CGM SENSORS
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Burn(s) (1757); Itching Sensation (1943); Scarring (2061)
Event Date 12/20/2020
Event Type  Injury  
Event Description
Started using dexcom g6 cgm around (b)(6) 2019 without any problems. Around (b)(6) 2020: started having severe itching while using dexcom g6 adhesive patch. Once patch removed, skin would appear "burned". Would have to use silvadene cream 3-4 times a day until sight was healed, but scarring would persist and take longer to heal. Reached out to company and was informed that the product was changed in early 2020 and now contained a new "hypoallergenic" adhesive product. Instructed me to attempt various barrier methods, which i did, without success. Stopped using product for several months. Attempted again to use product in dec 2020 with barrier adhesive, resulting in same side effect. Fda safety report id # (b)(4).
 
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Brand NameDEXCOM G6 CGM
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11222716
MDR Text Key228683716
Report NumberMW5098969
Device Sequence Number1
Product Code MDS
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/27/2021
Device Model NumberG6 CGM SENSORS
Device Catalogue NumberSTS-OR-003
Device Lot Number5274353
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: 01/22/2021 Patient Sequence Number: 1
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