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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM DEXCOM G5 CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM DEXCOM G5 CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Device Problem Invalid Sensing (2293)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 04/21/2018
Event Type  Injury  
Event Description
My son is a type 1 diabetic that uses a generation 5 dexcom continuous glucose monitor, to monitor his blood glucose levels. Recently, the fda approved the dexcom for making a treatment decisions such as dosing insulin or treating hypoglycemia. In the year we have used our dexcom we find it to be mostly accurate and mostly reliable. However, it also has unpredictable episodes of extreme inaccuracy. Today for example, our sensor was reporting a blood glucose level of 170, we then calibrated and discovered it was actually 308, we reoperated the manual finger stick test and got 304. If this incorrect data had been in the opposite direction, if it had reported 308 and he had actually been 170, our decision to give him insulin could have caused severe hypoglycemia. I believe it is unsafe to rely solely upon the dexcom to make treatment decisions and it will eventually result in someone's death or injury.
 
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Brand NameDEXCOM G5 CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceDEXCOM G5 CONTINUOUS GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
DEXCOM
MDR Report Key7457773
MDR Text Key106616818
Report NumberMW5076703
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 Family Member or Friend
Type of Report Initial
Report Date 04/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
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: 04/24/2018 Patient Sequence Number: 1
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