MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 CGM SENSOR; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSIVE DIABETES MANAG

Model Number G6

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2018

Event Type  malfunction  

Event Description

I've been using the dexcom g6 since (b)(6).They claim the sensors last 10 days, but i have had only 3 sensors last the full 10 days.They usually start giving me blood sugar readings that are at least 40-50 points off and repeated incidents of 'sensor error' where i received no readings for periods of time around day 6 or 7.These periods of inaccurate and no readings persist for the remainder of the 10 days.When this happens i have to go back to using my glucose meter up to 10 - 15 times a day to be able to adequately monitor my blood sugars.I have contacted dexcom with every sensor failure and they readily replace them.My problem is i have been a type 1 diabetic for over 50 years, and i am not always able to feel my low or high blood sugars, which is the reason i use the dexcom.I'm not sure if it's a quality control problem or what is causing these sensors to continually not last the 10 days.If they don't last 10 days, that interferes with my ability to have the required number of sensors to last until my insurance will cover the next shipment.I would go back to using the dexcom g4, but that was supposed to last 7 days and i rarely made to day 5 before problems started.I hope you can put some type of pressure on them to correct the fact that these sensors don't last 10 days for everyone.

• Brand Name: DEXCOM G6 CGM SENSOR
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSIVE DIABETES MANAG
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 8101886
• MDR Text Key: 128563221
• Report Number: MW5081587
• Device Sequence Number: 1
• Product Code: QDK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/22/2019
• Device Model Number: G6
• Device Lot Number: 5246152
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 66