• 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 Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Device Sensing Problem (2917)
Patient Problem Hyperglycemia (1905)
Event Date 12/18/2021
Event Type  Injury  
Event Description
I got alarms stating i would receive no readings. Give it up to 3 hours to come back. This happened for up to 20 minutes at a time a number of times throughout the night and next day. It went off at 11:30pm last evening, then back on at 12:30am this morning. I thought it was going to be ok, so did not change it. Changing it requires a 2 hour start up, and that leaves no readings, no pump suspension during that time. I do have night time low blood sugars. This morning, the cgm determined i was approaching a severe low, and suspended my pump. In actuality, based on a finger stick by an accurate meter (roche accucheck guide), my blood sugar was 176. The pump suspended, meaning my blood sugar went even higher. At 4:43pm, the same thing happened. I was in the 150s per finger stick, 'low' according to the cgm. This is the fourth sensor failure in as many applications. When a life is dependent on the device, it needs to work properly. I also filed a prior report for this same reason, last year. I am a registered nurse, certified diabetes educator and used to teach people how to use dexcom. It is not user error. I have photos of the discrepancy if needed. Thank you. 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 Key13061475
MDR Text Key282743878
Report NumberMW5106223
Device Sequence Number1
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
Type of Report Initial
Report Date 12/19/2021
4 Devices were Involved in the Event: 1   2   3   4  
1 Patient was Involved in the Event
Date FDA Received12/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG6
Device Lot Number7290476
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 12/21/2021 Patient Sequence Number: 1
Treatment
DEXCOM G6 CONTINUOUS GLUCOSE METER; TANDEM BASAL IQ INSULIN PUMP
-
-