Why it matters

When it comes to any medical device there is one inescapable fact; these devices fail and/or malfunction. This as they say comes with the territory. However, when an insulin pump fails or malfunctions it can, has and unfortunately does kill. As we keep repeating insulin when dosed improperly can kill a patient.

Today this issue is more complex than ever as insulin pumps have transformed from semi-smart devices largely controlled by the patient to automated systems which perform tasks for the patient. In today’s world where sensor augmented systems are becoming commonplace the glucose sensor delivers readings to the pump. The insulin dosing algorithm then analyzes this information and decides which action the pump is to perform.

Should the algorithm detect the patient is headed lower and could experience a hypoglycemic event the pump is told to suspend insulin delivery. When the opposite happens, the pump is told to deliver more insulin. In both cases the patient is excuse the expression taken out of the loop, the decision and execution of this decision is performed by the pump.

This is particularly true for the Medtronic 670G in auto mode. According to the Medtronic Diabetes web site auto mode does two things;

“Automatically adjusts your basal (background) insulin every five minutes based on your CGM readings

Helps keep your sugar levels in your target range for fewer lows and highs — day and night.”

The 630G again according to the web site has;

“SMARTGUARD TECHNOLOGY
Only the MiniMed system has SmartGuardtechnology, which takes action for you if your sensor glucose values go below a preset level.* If you don’t respond to alarms, SmartGuardtechnology can pause insulin delivery for up to two hours – giving you time to recover.”

As is clear the sensor as we keep saying is the straw that stirs the drink. The pump merely does what it is told to do, for all practical purposes the pump is the least important piece of this complex system assuming of course it functions properly. The insulin dosing algorithm is only as good as the information it receives from the sensor. The algorithm is not a piece of hardware it’s software which if written properly should function properly 100% of the time again assuming it gets accurate information.

The supplies that come with the system, the infusion sets, tubing and reservoir are just that supplies. The Infusion set is attached to the patient’s body, the tubing connects the pump to the infusion set and the reservoir holds the insulin. None of these supplies are smart, as Momma Kliff used to say they are dumber than a box of nails. Why then do you suppose over the past six months from March 1 to September 30 113 DEATHS have been attributed to the Medtronic reservoir.

Over that same time frame 42 DEATHS were attributed to the pump, 34 DEATHS to the sensor but 60% of the DEATHS were attributed to a piece of plastic which holds insulin. Now is it possible for the reservoir to malfunction sure, it can leak, crack or have some sort of issue with the O rings but let’s get real here unless Medtronic has forgotten how to manufacture reservoirs there should NOT BE 113 DEATHS attributed to a piece of plastic.

Just by way of comparison over that same time Tandem had 15 deaths, Insulet 20 and Dexcom 6. Medtronic had 200. Even with larger installed user base this alone does not explain the disparity. Nor can it explain how a reservoir can be attributed to 113 DEATHS.

Now Medtronic can tap dance all they want about the nature of adverse event reporting. They can sing like a canary about why they are classifying these issues as reservoir related. What they can’t do is dance like Fred Astaire or sing like Lady Gaga.

Perhaps this why the FDA has begun an investigation into how the company is reporting these events. Perhaps the FDA has looked at the same data we have and like us reasoned the reservoir has nothing to do with these DEATHS, that this piece of plastic is not in any way connected to these DEATHS. That there is no causal relationship here that the problem lies elsewhere.

Is it the sensor, is it the pump? Who knows. About all we know is the company is doing what they can to divert attention away from what is obviously a bigger costlier problem. The last thing they want, or need is the FDA to issue a warning letter or worse force the company to halt sales of their way cool whiz bang toy. Keep in mind we are only talking about DEATHS here. If you look at all adverse event reports over the that same time frame, issues attributed to the reservoir there are well over 500.

Even when accounting for double reporting, this does happen with adverse event reports, the numbers still do not add up. The numbers are just to glaring to be ignored that is unless you are Medtronic.

Anyone who is paying attention here, anyone but Medtronic, knows the sensor that comes with these systems is far from perfect. This critical piece of hardware the straw that stirs the drink does not work consistently. There are just too many accounts of inaccurate readings and sensor failures. As we have stated consistently when the damn thing works it can be a thing of beauty, the problem is it does not work with regularity which turns this prince into a frog.

Let’s be very clear here the last thing we or anyone wants is for the FDA to pull this system from the market. However, it is clear action needs to be taken and since Medtronic seems intent on not taking any it’s the FDA’s job to act. People’s lives are at stake here.