• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM GLUCOSE MONITORING SYSTEM

  • 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 GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number G5
Device Problems Device Alarm System (1012); Low Battery (2584); Battery Problem (2885)
Patient Problems Hypoglycemia (1912); Seizures (2063); Loss of consciousness (2418)
Event Date 10/08/2016
Event Type  Injury  
Event Description
My dexcom g5 app on my (b)(6) failed to alert me to a falling blood sugar set at 90 mg/kg and then at 55 mg/kg. This while i was experiencing low blood sugar symptoms and which i was trying to treat. I was without my transmitter for the g5 as the battery had failed on the (b)(6). It too (transmitter) was not reporting alarms either. My hypoglycemia resulted in seizure and black out. My (b)(6) alarm went off at 40 mg/kg. This is the first time in 45 plus years of a very active life with type 1 diabetes. I've never had a seizure or blacked out. I'm new to this product and was not made aware of the current issues with the transmitter or (b)(6) application as it pertained to alarms not working.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGLUCOSE MONITORING SYSTEM
Type of DeviceGLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
DEXCOM
MDR Report Key6069501
MDR Text Key58976354
Report NumberMW5065736
Device Sequence Number1
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/16/2016
Device Model NumberG5
Device Lot NumberSM69700371
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? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/28/2016 Patient Sequence Number: 1
Treatment
OTC MEDS: NONE. ; RX MEDS: OMNIPOD
-
-