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

Device Problems Low Readings (2460); Calibration Problem (2890); Device Sensing Problem (2917)

Patient Problem Hyperglycemia (1905)

Event Date 07/08/2021

Event Type  Injury  

Event Description

I was using a dexcom g6 sensor (lot # 5290547) and transmitter for my diabetes.I put on a new sensor and it takes two hours for it to warmup.I put the sensor on around 1030 pm.I went to bed and then around 12:30am, the app for the sensor that is on my phone caused my phone to start beeping to alert me that my sugar was very low and was going down fast.When i looked at my phone to see what my blood sugar reading was, it said 49.So being woken out of a sleep and seeing that my sugar was 45 with two down arrows indicating that my sugar was dropping very quickly, i jumped up and made some chocolate milk and started chugging it down.I started to make another one when i realized that i did not have the feeling of a 49 blood sugar.I can usually "feel it" when my sugar gets to about 70.So i went and grabbed my glucometer and checked my sugar.My sugar was 182.The dexcom sensor at the same time said that my sugar had dropped to 40 and there where still two double arrows pointing down (again, indicating that my sugar was dropping very fast).So i waited 15 minutes and checked my sugar again with my glucometer and my sugar was 197.Yet, the dexcom sensor was now reading 53.During all of this, at about 1:05 am, i attempted to calibrate the sensor.So i went through the process on the app to calibrate the sensor to the glucometer reading.I put the first blood sugar reading in of 182 and the app/sensor indicated that i needed to recalibrate after 1:16am, that there was a calibration error.So i rechecked my blood sugar and it was 197, i tried to calibrate the sensor again and i received the same error message, "calibration error." the app/sensor told me that i needed to recalibrated after 1:31am.At this point i stopped and took the sensor off and knew that it was no good.This is the second time in less than a month that this has happened with an extremely low blood sugar reading when i was starting a new sensor.The first time, i was actually driving my car and when the sensor finished its two hour warm up period, my phone started beeping indicating low blood sugar.I looked at my phone on that day and it said that my sugar was 59 with two down arrows indicating my sugar was dropping fast.I pulled my car over in an area where there was no cell service and i took three sugar tablets that i carry in my car.I waited a few minutes until my sensor updated and it said that my sugar was then 50.So i took three more sugar tablets thinking that my sugar must be dropping fast enough that i did not feel it or get any of my normal "feelings" that my sugar was dropping.The next reading i received on the app was 39.At that point, i realized that something was wrong and that my sugar probably was not 39.I was about 4 miles from my home so i started driving since i was unable to call someone for help.When i got home, i checked m blood sugar on my glucometer and my sugar was 248.I have had diabetes for 37 years.I know that over time, the "sensations" of low blood sugar change.In each of these cases, i panicked thinking that my blood sugar was dropping at a fast rate and i was not experiencing any of those normal "sensations." only to realize, some time later, that my blood sugar was not as low as what the sensor was telling me.Dexcom has been notified of both instances when this has happened.They should have the lot number of the first instance on file.After these two cases of these extremely low blood sugar readings, i cannot trust these dexcom sensors any more.These sensors should be taken off of the market until they can resolve this issue! what would happen if it was the other way around? what if someone checks their sensor reading and it says 187 when in reality they are 78 and dropping? please look into these sensors and see if there are any other cases like this.If so, please hold them accountable and make them resolve this issue.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 12159632
• MDR Text Key: 261480934
• Report Number: MW5102470
• Device Sequence Number: 2
• Product Code: MDS
• 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: 07/08/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 56 YR
• Patient Weight: 147