• 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. DEXCOMG6 CONTINUOUS GLUCOSE MONITOR 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. DEXCOMG6 CONTINUOUS GLUCOSE MONITOR SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033); Skin Irritation (2076)
Event Date 06/12/2020
Event Type  Injury  
Event Description
Noticed our daughter was breaking out in a horrible rash all over her chest and stomach, in reaction to the adhesive in the sensor strip, and the site was very red and angry looking, with a perfect indentation of the patch, when we removed it from her abdomen at the 10 day mark. We cleaned the other side of her abdomen and placed a new sensor but after 3 days, had to discontinue the continuous monitor all together due to the itching and severity of the rash. The second site was also red and angry looking, even after just 3 days use. We have spent the last week trying to clear up her skin and keep her reaction from going systemic. She began to break out in the rash on her face and back of her arms as well. Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDEXCOMG6 CONTINUOUS GLUCOSE MONITOR SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10173655
MDR Text Key195969307
Report NumberMW5095072
Device Sequence Number2
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 Family Member or Friend
Type of Report Initial
Report Date 06/17/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
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: 06/18/2020 Patient Sequence Number: 1
Treatment
ADVAIR DISKUS; FLONASE; GUMMY DAILY VITAMIN; ZYRTEC
-
-