• 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 G6
Device Problem Product Quality Problem (1506)
Patient Problems Rash (2033); Skin Irritation (2076)
Event Date 08/18/2020
Event Type  malfunction  
Event Description
Dexcom g6 adhesive on sensor is causing rash/skin irritation due to the adhesive that keeps product in place. Dexcom has said that they changed the adhesive at the end of 2019. I noticed a packaging change the last time i filled the prescription, which dexcom told me likely indicates that i am now getting the "newer" sensors. This has happened twice, with the rash located directly under and shaped just like the adhesive (oval). 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 Key10494164
MDR Text Key205954370
Report NumberMW5096440
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 09/02/2020
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received09/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/21/2021
Device Model NumberG6
Device Lot Number7275258
Was Device Available for Evaluation? No
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

-
-