• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEXCOM, INC. DEXCOM G6 SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number 9500-45
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Skin Irritation (2076); Fluid Discharge (2686)
Event Date 06/17/2020
Event Type  Injury  
Event Description
I've been having a serious allergic skin reaction to the updated dexcom g6 sensor adhesive (continuous glucose monitor). The last 4 sensors i've used have all resulted in a skin irritation on my skin, oval in shape, which takes about 30 days to heal. The reaction is mild to moderately itchy, very red in color, oozes exudate for about a week. Sometimes part of the reaction scabs over, but not always. Sometimes the skin is dry and flaky during the healing process (at 2-3 weeks). The skin reaction occurs even if i remove the sensor before the 10 days of maximum wear. I've been trying the dexcom recommended mitigation strategies for sensitive skin, including using both barrier films and patches. This seems to help but even with the mitigation strategies i still get an allergic reaction. Fda safety report id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDEXCOM G6
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10189354
MDR Text Key196466159
Report NumberMW5095180
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 06/20/2020
4 Devices were Involved in the Event: 1   2   3   4  
0 Patients were Involved in the Event:
Date FDA Received06/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/22/2020
Device Model Number9500-45
Device Lot Number5265223
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

-
-