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

Device Problems Display or Visual Feedback Problem (1184); Incorrect, Inadequate or Imprecise Result or Readings (1535); Material Integrity Problem (2978)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Event Description

Dexcom has released a new continuous glucose monitor called the g6 and ever since the g6 came out, i have had constant issues with the product.Nearly every single sensor i have used over the past 6+ months (that's minimum 18 sensors i've used) has not lasted the advertised 10 days.In fact they last half or less than half of that duration, usually displaying inaccurate sporadic blood sugar readings that are completely unreliable or failing with an error message altogether around day 4-6 almost every single time.I know this is a widespread issue because i am in some online groups with 20,000+ people who use the dexcom and experience the same issue.Myself nor the majority of these people ever had quality control issues when using the previous model of dexcom called the g5.Furthermore, there is a huge inventory mgmt issue with the dexcom g6.Every time i've tried to reorder my prescription when i am almost out of supplies, i get told the g6 is on a 10+ business day backorder, often resulting in having to go without the cgm device for days or even weeks at a time when i run out of supplies while waiting for the order to be fulfilled.I understand new products have supply chain issues sometimes, but this product has been on the market for over 6 months and this constant backorder has occurred since day 1 and they've had ample time to do something about it.No one's health should be jeopardized because a multimillion dollar company is dragging their feet whether it's just because it's poor mgmt or if it has to relate to their profit margins, etc, but this is unacceptable for so many people including myself to be put in this situation time and time again almost every time we go to refill our prescriptions.Our lives are already difficult enough having a chronic illness, having to worry about not having the necessary medical supplies and the added stress is completely unwarranted when it can be avoided.Not only is it stressful, a lot of people like myself are brittle diabetics and rely on the dexcom to save our lives.In the event of prolonged high blood sugars which can cause dka and a stroke or an immediate low blood sugar reaction which can cause seizures and death; it is much more difficult to know when to treat these occurrences without having a cgm constantly giving blood sugar readings.Also, people with these devices are typically prescribed less quantities of lancets and test strips for pricking their fingers since they are prescribed a cgm device so to even be able to test your blood sugar with finger pricks even as close to as frequently as with a cgm you run out of supplies very quickly and then have to come out of pocket for add'l supplies you did not budget for.Diabetes is already very expensive and some families are impoverished and can't even afford to buy the extra supplies that weren't budgeted for.All in all, it's unacceptable for the dexcom g6 to have such a high fail rate and constantly be on backorder causing people to go prolonged amounts of time with no cgm device.These issues have been discussed at length with dexcom by myself and many other people on multiple occasions over many months and no action has been taken to alleviate the issue so that is why i am reading out to the fda in hopes that an inquiry could be made into the quality control and inventory mgmt issues that dexcom is having regarding the g6 so that us consumers can get advices that worked as advertised on a proper scheduled basis.Thanks.

• Brand Name: DEXCOM G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM INC.
• MDR Report Key: 8180569
• MDR Text Key: 131306323
• Report Number: MW5082274
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/17/2018
• 16 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 23 YR