Something amiss …..

Something amiss …..

Last Friday Tandem stock came under a short attack with short sellers posting news of a death of a patient who was using a Tandem pump. Now before we go any further a few words about the FDA adverse event reporting system, which is vastly outdated, subject to wide interpretation, abused constantly yet the only system we have. Medical device companies are given an incredible amount of latitude as what they report and how they report. Some report every little incident no matter how inconsequential, others seek to avoid reporting until absolutely necessary.

Now we should say that anyone who wears an insulin pump and dies is typically the subject of an adverse event. This DOES NOT mean the insulin pump caused the death, rather the death occurred while the person was using the insulin pump. There is a HUGE difference with causation which implies the insulin pump is responsible for the death. This is typically when the lawyers get involved and could signal a larger issue with the insulin pump system itself.

In the case of Tandem it was not determined that the insulin pump caused the death rather the patient was using a Tandem insulin pump at the time of death. Here is the exact event description from the MAUDE database;

“It was reported that the customer passed away. Cause of death is pending determination by coroner. Per coroner, customer’s blood glucose was reportedly very low at around the time of death. No additional information was provided.”

The report further states;

“The device is expected to be returned; however, the device has not yet been received. A supplemental report will be submitted if the device is received.”

This is fairly typical and really isn’t any cause for concern, however to the untrained eye reports such as these are always alarming. Having examined several of the reports Tandem has submitted to the FDA it does not appear there are any issues with any of the Tandem systems. Yes it is unfortunate when any patient dies however it does not appear there are any issues with any Tandem insulin pump. Sadly these things happen but here the cause lies elsewhere not with Tandem.

Now compare this to some of the reports we read submitted by Medtronic;

“Medtronic legal received information regarding the customer¿s passing from the attorney of the family. The information received on September 23, 2019 stated only that the customer was deceased. The reporting party did not state when the customer began using an insulin pump. There had been a previous report from the family attorney that the customer had a high or a low blood glucose event. No further information was obtained.”

“Medtronic legal received information regarding the customer’s serious injury and death from the attorney of the family. The information received on (b)(6) 2017 stated the following – reporter alleges: in or about 2006 the customer began using an insulin pump. In (b)(6) 2013, the customer was using a medtronic minimed paradigm pump. On or about the (b)(6) 2013, the customer experienced severe hypoglycemia caused by a malfunction of the insulin pump, reservoir, and infusion set. The customer got into a motor vehicle accident and was attended by paramedics. The incident resulted in cognitive impairment, a motor vehicle accident, subsequent injuries, hospitalization, and eventually death. The customer had the car accident on (b)(6) 2013 after an over delivery incident due to the am/pm time setting getting reversed on the insulin pump. This reversal adjusted the basal rate of insulin that the customer was receiving. On (b)(6) 2016, the customer suffered a second motor vehicle accident due to his impaired cognitive capacity and passed shortly thereafter. The customer passed due to complications from the accident and the reconstructive hardware they had from the first accident.”

“It was reported via legal documents that the customer passed away in an unknown location. The cause of death was an apparent insulin overdose which resulted in the customer’s passing. The notifying party did not state whether the customer had any illnesses that may have led to the customer’s passing. The customer¿s blood glucose was unknown at the time of death. The customer was most likely wearing the insulin pump at the time of death. It is unknown if the customer was using sensors. The notifying party did not state whether they would return the insulin pump for analysis.”

These are three separate reports all involving Medtronic legal which means once again the Evil Empire will be the subject of yet another lawsuit. Now we are no in way implying that Medtronic has done anything illegal or criminal, that is for the courts to decide. What we do know, what everyone knows is that there are a host of issues with the 670G, most directly tied to the CGM sensor, and this way cool whiz bang system is great when it works as designed but can be lethal when it doesn’t.

We also noticed while doing our research that Medtronic is still trying divert the FDA’s attention away for the problem but classifying some events as reservoir related, others infusion set related, still others pump related when the real problem is the system itself. We have written about this previously but is worth reviewing as the adverse event reporting system was not designed for the current world of hybrid closed loop insulin delivery systems.

Remember a hybrid closed loop insulin delivery system contains the following components – the insulin pump which delivers the insulin – the CGM which collects glucose readings and the insulin dosing algorithm which calculates when or if to deliver insulin. Think of this as links of a bicycle chain which when working offers a smooth ride, however should any link in the chain break the entire system malfunctions and the bike doesn’t ride.

Again as we have written in the past the CGM sensor is the most critical link in this chain as the data collected from this sensor is feed into the algorithm which then determines when or if to deliver insulin. Send in the wrong reading and the system as it designed will then either deliver too much insulin causing hypoglycemia or halt insulin delivery causing DKA, both life threatening situations.

Yes the pump could malfunction independently and there are very rare occasions that the reservoir could malfunction but given how these systems are designed and manufactured, these malfunctions typically are rare. In the Medtronic case given that all the parts are designed to work as one it is much more likely that the entire system failed due to a malfunction in one of its many parts. This is different than the Tandem situation which combines a Tandem insulin pump, a Tandem insulin dosing algorithm and a Dexcom CGM. (The coming Control IQ will use the TypeZero insulin dosing algorithm which is now owned by Dexcom.)

What is very bothersome in addition to these systems malfunctioning is the involvement of Medtronic legal. Now we will not say this is a Watergate moment, when did they know and did they cover it up. However it is very well known that CGM sensor is unreliable and can and does deliver inaccurate readings. As we have stated since the 670G went on the market, when the damn thing works as designed it’s a wonderful system. Yet when it fails or malfunctions it can turn into a killer.

Worse still is given how the legal process works Medtronic could settle any lawsuits, put a gag order in place and the public will never know. This is why we were so encouraged when we learned that FDA had begun investigating Medtronic and their adverse event reporting protocol. We do not know if this investigation is ongoing or completed, the FDA as always will not publicly confirm or deny the existence of any ongoing investigation or completed investigation or whether there even was an investigation.

The reality here is patients, their physicians, CDE’s everyone needs to know what’s going on so they can make an informed choice when it comes to selecting an insulin pump. While it shouldn’t be this way when it comes to choosing a Medtronic system it may be a matter of life or death.