What’s going on in Northridge?
As everyone knows sensor augmented insulin pumps are the hottest toy in the toy chest. Yet as we keep saying the least important link in this chain is the actual insulin pump. For all practical purposes the pump just does what it’s told to do. The CGM sensor and the insulin dosing algorithm are the real engines that drive this fancy new car. So, what happens when the CGM sensor either doesn’t work or worse delivers inaccurate readings?
What you get are comments like this;
“It was reported that, the sensor had inaccurate readings that triggered threshold suspend alarm. The customers blood glucose was 8. 9 mmol/l and the sensor glucose was 5 mmol/l. The customer was informed that their blood glucose and sensor glucose levels were not in acceptable range. Sensor glucose and blood glucose difference was 3. 9 mmol/l. Insulin delivery was suspended due to sensor glucose values. Sensor glucose value that triggered the suspend event was 5 mmol/l. Threshold and low suspend limit in sensor settings was 3. 5 mmol/l. The sensor will not be returned for analysis.”
“It was reported that the sensor had inaccurate readings that triggered threshold suspend alarm. The customers blood glucose was 138 mg/dl and the sensor glucose was 68 mg/dl. Insulin delivery was suspended due to sensor values. Sensor value that triggered the suspend event was 68 mg/dl. Suspend on low limit in sensor settings was 70 mg/dl. The customer was informed that their blood glucose and sensor glucose levels were not in acceptable range. The sensor will not be returned for analysis.”
“It was reported that the sensor had inaccurate readings that triggered threshold suspend alarm. The customers blood glucose was 138 mg/dl and the sensor glucose was 68 mg/dl. Insulin delivery was suspended due to sensor values. Sensor value that triggered the suspend event was 68 mg/dl. Suspend on low limit in sensor settings was 70 mg/dl. The customer was informed that their blood glucose and sensor glucose levels were not in acceptable range. The sensor will not be returned for analysis.”
We could go on here but why. As these comments from the FDA’s MAUDE database make clear sensor accuracy is important and lack of accuracy has consequences. And yes, all of these reports, and there are lots more, are related to the Medtronic system. Which makes us wonder what the folks in Northridge are doing these days especially now that they have entered the stand alone CGM market.
We aren’t exactly sure with these widely circulated reports, yes patients do complain about this issue on social media, how the company plans to compete with two systems that are far superior not just in terms of being easy to use but where it counts accuracy. This is even more problematic as the company has publicly stated that they will put lipstick on this pig and generate a billion dollars in sales.
Yet sensor accuracy as big a problem as it is, is not the only issue facing the empire. The company has issued safety notices due to alarm issues with the 670g and 630G. Letters are being sent out notifying patients of supply issues with reservoirs. This follows other issues they have had in the past supplying sensors.
This unfortunately also follows a pattern. As everyone knows Medtronic owns the insulin pump market using their scale as a hammer to knock down the competition. They are not out innovating the competition they are beating them into submission using their scale and financial resources. We don’t have a problem with this as this is how capitalism works.
However, as we have noted this could be a huge problem for the team running diabetes as each time the golden goose looks to be threatened its time for team members to start updating their resumes. And as has happened in the past each time the golden goose looks in danger the wounds are self-inflicted and this time it doesn’t look to be different.
But there is an even bigger problem this time around as unlike in the past the solution isn’t so simple. Tandem has their new toy on the market and will soon have a serious competitor to the 670G. The company has a nightmare on their hands as the hardware for the 670G will need to be replaced and given the company’s history when it comes to situations like these they will not perform well. Do they give away the new hardware, do they charge for it?
It’s also well known that the Animas conversion isn’t going well. Which does not bode well as the company publicly stated they expect diabetes to grow at mid to high double digits something that will not happen if they don’t fix this situation.
We have stated for some time that even with its huge installed user base and vast financial resources this unit is more vulnerable than ever before. That the goose that lays those golden eggs could become an albatross around the neck of management. That if they don’t get their act together and look at things the way they are instead of the way they want them to be, it will be don’t let the door hit you in the rear on your way out.
As Momma Kliff used to say, “You can only ignore reality for so long for as ugly as reality may be you at some point have to face it.”
