MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6CONTINUOUS GLUCOSE MONITORING DEVICE; INTEGRATED CONTINIUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSE DIABETES MANAG

Model Number G6

Device Problems Computer Software Problem (1112); Loss of Data (2903)

Patient Problem Hypoglycemia (1912)

Event Date 01/17/2020

Event Type  Injury  

Event Description

My name is (b)(6) and i and the legal primary caregiver of my mother (b)(6).My mother has been type 1 diabetic her entire life , and was recently diagnosed with moderate-severe level alzheimer dementia.We use a continuous glucose monitoring system (cgm) by dexcom to transmit her glucose levels from her sensor to my phone.A subcutaneous sensor wire measure and transmits her glucose levels via bluetooth to her phone, then from her phone to dexcom servers, then from the servers to my phones¿ dexcom follow app.This device is an absolute necessity in our home as cognition and language issues prevent her from caring for herself.We began using their product in (b)(6) 2018 (g5 system), and upgraded to the (g6 system) (b)(6) 2019.On (b)(6) 2018, the dexcom servers went down.When the servers go down, data is not transmitted to the followers/caregivers app.When data isn¿t being transmitted, alarms go off on the followers app.So on (b)(6) 2019, i was home bound all day and night side by side with my mom.Luckily however the servers and app became functional the next day.On (b)(6) 2019, the dexcom serves went down again.This time lasting an entire week.I had spent many hours on hold with dexcom to no avail.I requested call backs with no result.My best source for updates and communication was on their (b)(6) page.On (b)(6) 2019 they announced that their services are back up and running, except for a few people who tried to troubleshoot the issues themselves, me being on of those people needed some extra assistance.On (b)(6) 2019, dexcom follow app sporadically shows no data or disconnected, resulting in alarms.They announced a fix on their (b)(6) page which i did, with no luck.For the past 2 months, i have been getting up multiple times between the hours of 12am-5am because the follow app alarms me of no data being transmitted.But when i check on the welfare of my mother, her sensor is fine and is connected to her phone and transmitting to the servers.Being a caregiver is difficult enough already, these errors are affecting my health as the caregiver due to lack of sleep or trust.So the error is yet again on them.I tried calling their technical support number various times and even requested call backs.After many failed attempts of trying to reach them, i finally did today (b)(6) 2020.I informed them of everything i¿m having issues with.They ran me through their troubleshooting steps, most of which i had already done.What was said next to me over the phone made me report this.I was instructed to go into my phone¿s operating system settings and turn off the automatic updates.I immediately said i will not do that as i could miss serious operating system updates and this creates serious security vulnerabilities for us and other patients.The lady i was speaking with informed me that they cannot keep up with operating system updates of various platforms.To combat the compatibility issue they just have the patients turn off automatic updates.I said that¿s absolutely unacceptable to do that.We pay for a medical service that has been fda approved and the burden of the company¿s failures are being put onto the patient.We, the caregivers are suffering the most.We rely on this device to function properly and it hasn¿t been delivering.I requested a case number for the future reference (b)(4).I strongly urge whomever is reviewing this to also look at dexcom¿s (b)(6) account for the dates during the server outages.The comments and stories will not only blow your mind, but also paint the bigger picture of this company¿s inability to perform and deliver services and deliver services rendered safe, accurate, and reliable.And there are lots of us this is happening to.I thank you for taking your time to read this, (b)(6).Missed hypoglycemic events.Dexcom clarity software collects and shares all data with the patient and the endocrinologist team.The graphical readout will show various low glucose readings, ones below 60mg/dl were generally a result of data not being shared with me, the caregiver.Luckily i¿ve been able to identify, reverse, and stabilize the event before serious injury occurred.Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6CONTINUOUS GLUCOSE MONITORING DEVICE
• Type of Device: INTEGRATED CONTINIUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSE DIABETES MANAG
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 9622846
• MDR Text Key: 176546288
• Report Number: MW5092455
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G6
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 57