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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE METER SENSOR, GLUCOSE, INVASIVE

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DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE METER SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number G6
Device Problems Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)
Patient Problem Hypoglycemia (1912)
Event Date 02/21/2021
Event Type  Injury  
Event Description
Undetected hypoglycemia; continuous glucose meter displays 'sensor error' and does not communicate with the insulin pump that is supposed to suspend insulin delivery when there is a predicted low blood sugar. This has happened with 9 of 10 sensors. This last one went bad before receiving the replacement of the previous one that went bad. The replacements are also not working correctly. This can be a life or death situation when dealing with a low blood sugar. I have photos of the gaps in cgm-pump/phone communication. I also have a photo of my pump being suspended when no communication was received from undetected. When calling dexcom for the problem, i have always been referred to tandem (my pump company) for replacement of the malfunctioning sensor. Dexcom is not taking ownership of the problem, and nothing has been done to correct it. Fda safety report # (b)(4).
 
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Brand NameDEXCOM G6 CONTINUOUS GLUCOSE METER
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11372256
MDR Text Key233555657
Report NumberMW5099578
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 02/21/2021
9 Devices were Involved in the Event: 1   2   3   4   5   6   7   8   9  
1 Patient was Involved in the Event
Date FDA Received02/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/24/2021
Device Model NumberG6
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: 02/23/2021 Patient Sequence Number: 1
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