DEXCOM G6CONTINUOUS GLUCOSE MONITORING DEVICE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-22 for DEXCOM G6CONTINUOUS GLUCOSE MONITORING DEVICE manufactured by Dexcom, Inc..

Event Text Entries

[176546288] 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).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5092455
MDR Report Key9622846
Date Received2020-01-22
Date of Report2020-01-17
Date of Event2020-01-17
Date Added to Maude2020-01-23
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDEXCOM G6CONTINUOUS GLUCOSE MONITORING DEVICE
Generic NameINTEGRATED CONTINIUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSE DIABETES MANAG
Product CodeQDK
Date Received2020-01-22
Model NumberG6
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerDEXCOM, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2020-01-22

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