• 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 CONTINUOUS GLUCOSE MONITOR TRANSMITTER 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 CONTINUOUS GLUCOSE MONITOR TRANSMITTER SENSOR, GLUCOSE, INVASIVE Back to Search Results
Lot Number 5277362
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem Insufficient Information (4580)
Event Date 06/29/2021
Event Type  Injury  
Event Description
Data from this device, dexcom g6, are used for precise treatment decisions that sustain life. If errant data is used or if data is absent, errant decisions may be made, resulting in too high or too low blood sugars, potential dka, seizures, or even death. We have been using this device for nearly two years, on our son, and have had trouble with getting accurate data from it many times. Sometimes it doesn't give data at all. The tag line for advertisement of this product is "zero finger sticks", and that is anything but accurate. In this particular incident, we replaced our son's dexcom transmitter 30 days ago, and have had errant readings, dropped readings, false lows, jumpiness, signal losses, sensor errors, and had to replace 3 sensors, as well as the transmitter prematurely. We have done many, many finger sticks, and had to give rescue sugar when we normally would not have. We also have given rescue sugar based upon false lows, and sent him high. Our sleep has suffered greatly, as well, and we, his parents, are suffering because of lack of sleep, mental stress, and anxiety over all of this. Fda safety report id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDEXCOM G6 CONTINUOUS GLUCOSE MONITOR TRANSMITTER
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key12108104
MDR Text Key260145136
Report NumberMW5102262
Device Sequence Number2
Product Code MDS
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 06/29/2021
4 Devices were Involved in the Event: 1   2   3   4  
1 Patient was Involved in the Event
Date FDA Received07/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number5277362
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: 07/01/2021 Patient Sequence Number: 1
-
-