• 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 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 SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number G6
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Rash (2033); Skin Inflammation/ Irritation (4545)
Event Date 08/20/2022
Event Type  Injury  
Event Description
I've been wearing a dexcom cgm for a little over a year. The last several sensors i've put on have caused a severe skin allergy, one of the sites has turned into an infection with an open wound since may. I wear the device on my abdomen where it is approved to be worn. I have reached out to the company and they do send new sensors, but they caused the same reaction. I have several pictures of the rash and the open wound has cost me a fortune in doctor visit when it had to be packed twice a week. I have seen several "tricks" so the rash doesn't happen, but none of them are recommended by the company. When i have asked what they recommended i was sent overpatches which is not the issue. I realize a skin rash isn't a big deal, but when they can turn into an infection, into an open wound, for a diabetic that can mean death. The pictures i have included are of the rash caused by several different sensors. Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDEXCOM G6 SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key15283047
MDR Text Key298704851
Report NumberMW5111683
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00386270000255
UDI-Public(01)00386270000255
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 08/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG6
Device Catalogue Number9500-45
Device Lot Number7300435
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

-
-