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

Model Number G6 SENSOR

Device Problems Defective Alarm (1014); Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Sense (1559); Failure to Read Input Signal (1581); Defective Device (2588)

Patient Problems Hypoglycemia (1912); Convulsion/Seizure (4406)

Event Date 07/14/2021

Event Type  Injury  

Event Description

My dexcom g6 cgm said i had a 78 glucose level at approximately 4:40 pm on (b)(6) 2021.I ate 35 g of carbs and took no insulin before i started driving to the pool.About 15 minutes later i went off the road, doing extensive property damage and totaling my car.Fortunately i didn't hit anyone or any animal.People pulling me from my car said i was spasming or looked to be having a seizure.Paramedics checked my blood sugar with a blood glucose meter and it was in the 40s, and this was after i started drinking a regular coke (i.E., one with sugar).My dexcom g6 receiver said i was "low" when i was helped from the car and it started to climb with my drinking the coke.The thing is the receiver didn't alert me to my low glucose level prior to the accident even though i had the receiver on the front passenger seat right next to me.If it had alerted me, then i would have safely pulled over my car and stopped driving.I would have treated my low glucose level before attempting to drive again.Instead i had a terrible car accident, which could have killed or seriously injured someone including myself.I damaged property of a landowner, lost my car, and lost my license.My driver's license has been indefinitely suspended due to immediate threat - medical by the state of (b)(6).I used to check my blood sugars before i drove but stopped doing that because a cgm (continuous glucose monitor) with low glucose alerts made it unnecessary.Or so i thought.But the dexcom g6 didn't alert me when it was supposed to, whether due to a defective transmitter (activated on (b)(6) 2021 and currently showing low battery life) or defective sensor (inserted (b)(6) 2021), or both.I suspect i didn't get an alert when my glucose level was 55 and falling because of a combination of a defective transmitter and defective sensor.It is amazing to me that i didn't get a low glucose alert because i'm frequently awakened in the early morning hours with these alerts.Usually i just take the readings as gospel and treat the low glucose levels with regular (b)(6) or candy.Occasionally i will check my blood sugar with my blood glucose meter, especially when i don't feel like i have a low glucose level.Too often the dexcom g6 cgm has been wrong and i don't have a low glucose level.I have also had many sensor errors and signal losses with this cgm about 6 out of my last 10 sensors have been problematical.I have called dexcom and received replacement sensors, but it had gotten to be such an annoyance i informed my diabetes doctor i didn't want to use dexcom anymore.Immediately after i got into the car accident due to the lack of a low glucose alert, i messaged my doctor asking for prescriptions for the freestyle libre 2 reader and sensors.His staff obliged and i recently got the freestyle libre 2 cgm.I'm going to apply it in the morning after i read all the instructions and charge it up.I hope it's a lot better than the dexcom g6 cgm.However, i will always perform a fingerstick/blood glucose test before driving again.That is if i ever get my driver's license back.Fda safety report id # (b)(4).

• Brand Name: SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 12210869
• MDR Text Key: 263505863
• Report Number: MW5102717
• 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: 07/20/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G6 SENSOR
• Device Catalogue Number: STS-OR-001
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: (B)(6) HIGH POTENCY CHEWABLE (MULTIPLE VITAMIN AND MINERAL FORMULA)
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 57 YR
• Patient Weight: 66