• 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 M24078
Device Problem Failure to Sense (1559)
Patient Problems Dizziness (2194); Confusion/ Disorientation (2553)
Event Date 02/14/2019
Event Type  Injury  
Event Description
My dexcom g6 sensor repeatedly fails. It is to check my blood sugar. I contacted tech support for a replacement and it seems that only ends up needing to be replaced soon after i place it anyhow. I was hospitalized after my sensor failed. I experienced dizziness and confusion. I contacted technical support and was only asked to reply with the best time to reach me. Also, they provided a website to use which is no longer being supported. Further upsetting is that my sensor today also failed and that¿s my last one. I need them to send a replacement. I also need something other than ¿due to high call volume, your wait may be longer than expected¿ to be the hold music. It is infuriating that it¿s nearly impossible to get through to them. I need them to send a replacement sensor to my home address on file.
 
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 Key8392344
MDR Text Key137984312
Report NumberMW5084647
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM24078
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: 03/05/2019 Patient Sequence Number: 1
-
-