Oh Canada

Yesterday Canada cleared the 670G per a press release;

“Medtronic of Canada Ltd., a subsidiary of Medtronic plc (NYSE: MDT), today announced it has received a licence from Health Canada for the MiniMed™ 670G system — the first insulin pump system in Canada that helps to stabilize glucose levels 24 hours a day by automatically adjusting basal insulin delivery based on real-time insulin needs.1 This new system allows people with type 1 diabetes to take greater control of their disease through increasing levels of automation that minimize exposure to both high and low blood glucose levels.”

Now we must admit we are big fans of Canada as after all this country invented one of our favorite sports, hockey. And who doesn’t like Canada’s national anthem. Yet our neighbors to the north might be in for a few surprises. As we outlined yesterday the FDA’s MAUDE database is filed with reports on the 670G, sensors and believe it or not reservoirs.

Before we go any further let’s make something crystal clear when the damn thing works the 670G is a fine system. However, the problem starts when the damn thing doesn’t work. An even bigger problem is when it doesn’t work what is supposed to be a life saving device becomes a killer. As we have stated in the past insulin when improperly dosed is lethal. On the flip side this system which is supposed to detect and prevent serve hypoglycemic events, also life threatening, becomes useless when it fails to detect and prevent them.

Remember every closed loop system is collection of devices designed to work together. When all the links in this chain work the bike rides just fine. However, when any link breaks the entire chain falls apart and the bike doesn’t ride at all. Based on the numerous adverse events reports we have been reading there is no question the Medtronic CGM sensor is a big part of the problem. Again, as we have stated consistently it’s the CGM which is the straw the stirs the closed loop drink.

This is even more important with the 670G as Medtronic is pushing patients into using the system in auto mode. Which is fine when the damn thing works but a disaster when it doesn’t. When the sensor fails or delivers incorrect readings the entire system falls apart. As we noted yesterday the pump itself just does what the algorithm tells it to do, an algorithm which makes decisions based on the data it’s provided by the sensor. Or as our professors used to say when you put garbage in you get garbage out.

Is it any wonder that Medtronic is having a difficult time converting Animas patients to their new toy? If there is one thing everyone should know is the insulin pump community is the most vocal diabetes community. And word is spreading that this way cool whiz bang toy isn’t that cool after all. Yes, there are patients who love the toy but there is a growing group that is questioning whether it’s worth the risk. Patients who now have a credible alternative with the Tandem Basal IQ which works with the best CGM sensor on the planet, a sensor that is accurate.

Are we finished yet, not by a long shot. While looking through the MAUDE database we came across a strange and very confusing issue related to the reservoir. As we noted yesterday Medtronic has sent out letters which state;

“We are reaching out to inform you that we are currently experiencing supply constraints for our MiniMed™ Reservoirs, which means that some of your patients will experience delays in receiving their reservoir shipments.”

Now this seems innocent enough until you start reading the adverse event reports related to reservoirs. Here are some samples of what we are talking about and keep in mind there are a number of these;

“The customer reported via phone call that they experienced high blood glucose of 458 mg/dl. Troubleshooting was declined for high blood glucose. The devise will not be returned for analysis.”

“It was reported via phone call that the customer experienced high blood glucose. The customer’s blood glucose level was 400 mg/dl at the time of the incident. The insulin pump will not be returned for the analysis.”

“The customer reported via phone call that they experienced high blood glucose. The customers blood glucose level was 450 mg/dl. The customer declined troubleshoot for high blood glucose. The product will not be returned for analysis.”

Granted there are several reports which relate to leakage and the like, issues which can be directly linked to the reservoir, this is not unusual. And given the letter that was sent out it sounds like this may be a quality control issue. Not a good thing but something that can be fixed more easily than say a structural problem with the pump itself or the insulin dosing algorithm.

Yet the reports we quoted have nothing to do with the reservoir or maybe we should say cannot be directly linked to the reservoir. Here’s where things get shall we say hinky as it is Medtronic who classifies the nature of each adverse event report. It is Medtronic who chooses what to call this event. Just by way of example other reports fall under the Sensor Enlite or PARADIGM REAL-TIME REVEL INSULIN INFUSIO brand category.

Now we are not accusing the company of anything nefarious however they could well be playing a game of semantics therefore disguising what could be a much bigger problem with the pump itself, the software, the sensor or the insulin dosing algorithm. Given the huge size of their installed user base it is no way unusual for Medtronic to have a larger number of these reports. When you’re the big dog in the yard you make a bigger mark then the little dogs. Still these reports and how they are being classified just doesn’t pass the smell test.

Our gut and 20 years of covering this wacky world tell us that the problems are bigger than the company is letting on. That the last thing they want is the FDA to take a closer look. Now we could be all wrong, but we just don’t think so. Talk with anyone in the real world and basically what you hear is either patients love the 670G or they hate it, there is no middle ground. As we said earlier when it works it’s wonderful, however when it doesn’t it flat-out sucks.

We have reached out to Medtronic for comment but have yet to hear from them. They have promised to discuss these issues with us and we will publish their response should they get back to us. Whether the folks in Northridge realize it or not this has nothing to do with our dislike for the company or the products they make. We do not dislike any company in our wacky world. And Medtronic does not make poor products by any stretch of the imagination.

This is all about what it should be about patients. What these reports tell us combined with our gray hairs is the company has taken their eye off the ball. We can say this with sincerity as we have consulted for the company and did our best to warn them of some of the very issues that are appearing. We fully understand the complexities of how this business works and appreciate the difficulties of getting things done when all everyone seems to care about is the next quarterly earnings report.

Still what made MiniMed great back in the day was they proved they could put the patient first and still make boatloads of money. These two goals are not incongruent as some think and actually go hand in hand.