DEXCOM G6 CGM SENSOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-23 for DEXCOM G6 CGM SENSOR manufactured by Dexcom, Inc..

Event Text Entries

[128563221] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5081587
• MDR Report Key: 8101886
• Date Received: 2018-11-23
• Date of Report: 2018-11-21
• Date of Event: 2018-11-21
• Date Added to Maude: 2018-11-26
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: DEXCOM G6 CGM SENSOR
• Generic Name: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSIVE DIABETES MANAG
• Product Code: QDK
• Date Received: 2018-11-23
• Model Number: G6
• Lot Number: 5246152
• Device Expiration Date: 2019-09-22
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DEXCOM, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2018-11-23