The MiniMed Recall – Something isn’t right here
Webster’s dictionary defines recall as “to call back, ask or order to return: specif., to ask purchasers to return (an imperfect or dangerous product), often so that a manufacturing defect can be corrected” Based on what Diabetic Investor is learning it appears the FDA and Medtronic (NYSE:MDT) are using a much different definition for what a recall is.
Yesterday Diabetic Investor reported on the recall of all Medtronic Paradigm insulin pumps. According to the FDA’s enforcement report the reason for the recall-
“Exposure to Magnetic Resonance Imaging (MRI) has resulted in damage to the component that monitors and controls movement of the motor in the MiniMed Paradigm insulin infusion pump. Although there were alarms as a result of the damage, some users cleared these alarms and continued using the pump. Under such conditions, the pump will significantly over-deliver: potentially causing severe hypoglycemia.”
Diabetic Investor questioned the FDA decision to mark this as Class II recall based on the fact that severe hypoglycemia can be a life threatening situation. According to the University of Pennsylvania Health System web site- “Untreated hypoglycemia can progress to unconsciousness and if the brain is exposed to reduced glucose for a long period of time, there may be permanent damage.”
It seems as though the FDA does not see the risk of a patient going into a coma or the possibility of permanent brain damage as a serious health risk.
For their part Medtronic (NYSE:MDT) is doing their best to position this recall as much to do about nothing. They correctly state that manual for the pump warns the patient about this situation. According to the manual for the Paradigm 522 and 722 on page six it states:
“X-rays, MRIs and CT scans
If you are going to have an X-ray, CT scan, MRI or other type of exposure to radiation, take off your pump, meter and remote control and remove them from the area.
The Paradigm pump is designed to withstand common electromagnetic interference, including airport security systems. Be sure to carry the Airport Card provided when you are traveling.”
Type in MRI at the MiniMed web site and you get the following response:
“It is not safe to expose your pump to the following test:
An MRI (magnetic resonance imaging) test uses extremely powerful magnetic fields and radio frequency waves to create images of internal organs from the body. These strong magnetic fields can damage the pump and potentially pull it from your body. The infusion set can be left in your body without concern.
Medtronic MiniMed recommends that you temporarily disconnect your pump before entering the room in which the procedure is to occur.”
The company also they sent letters to patients, physicians and distributors back in April, a copy of which is attached to this email alert.
Still it seems strange that there is no mention of the recall on the web site or that there is virtually no chatter on internet. According to Michael Robinton Executive Director of Insulin-Pumpers.org the most popular web site for insulin pump patients, “I don’t think anyone was aware of it. These things are always discussed on the list and I’ve not heard a peep.”
Looking over yesterday’s postings on the site MiniMed patients are experiencing the same problems Diabetic Investor had when we called the company’s technical support line.
It seems as though the people who are supposed to handle patient questions have not been properly educated and are falsely telling patients there is no recall.
Diabetic Investor has also contacted several physicians with a large volume of MiniMed pump patients who indicated they have heard nothing from their patients or the company. It is the exception rather than the norm when a physician indicated they were aware of the issue.
Also attached to this email is an adverse event report that specifically mentions a pump being exposed to a MRI. It’s worth noting that the date on this particular event was June 6th. While searching the FDA’s adverse event database Diabetic Investor also found one incident where a patient died, according to the report the patient experienced serve hypoglycemia while driving, passed out and crashed. This particular report does not specifically mention any relation to the MRI issue but is a clear illustration of just how serious severe hypoglycemia can be.
Prior to being acquired by Medtronic, MiniMed was known for outstanding customer service. Shortly after being acquired by Medtronic the company made the foolish decision to cut back on customer service, a decision that cost the company dearly and was partially responsible for the early success of Animas and Deltec. Diabetic Investor has long maintained that had Medtronic not made such a foolish move, neither Animas or Deltec would have been able to gain more than a sliver of market share. By the time the company realized they had a mistake and corrected the problem the damage was already done.
Today the company holds a commanding presence in the market with the largest installed user base and a 70%+ market share. Based on all available evidence it appears the company has once again decided that profits come before customer service. The company claims they have been proactive with this latest issue and acted in the best interest of the patient. Diabetic Investor does not see it that way. From our point of view the company tried to sweep this issue under the rug hoping no one would notice. The fact that customer support representatives are giving out false information is inexcusable. Insulin pump patients are dependent on their devices and need to know ALL the issues that may affect the device that keeps them alive. Considering that the majority of insulin pump patients are Type 1 and hypoglycemia is a serious problem the company had a moral obligation to make every attempt to contact patients and physicians.
How it can be that so many patients and physicians are not aware of this issue when the company claims they sent out 210,000 letters? Why is there no chatter on the internet among insulin pump patients? Something isn’t right here and quite frankly it’s time Medtronic was taken to task for trying to keep this issue from the public.
Equally culpable is the FDA and their decision to classify this recall as a Class II rather than Class I recall. How many patients need to be hospitalized or die before the agency realizes that severe hypoglycemia is a serious situation?
Diabetic Investor does not believe that Medtronic should be forced to replace every Paradigm pump in the market. As we stated previously insulin pump patients are dependent on their devices and cannot easily switch to another therapy option. However this fact does absolve the company from their responsibility to provide ALL information to patients and physicians. If as the company claims the patient can run a simple diagnostic test to determine whether their particular pump has a problem this shouldn’t be a big deal. Which begs the question, if the company and FDA are correct and this really is no big deal, why didn’t Medtronic at least issue a press release so that patients could learn of the issue and simply run the diagnostic?
The bottom line here is that something isn’t right here and this situation doesn’t pass the smell test.