MiniMed Recalls ALL Paradigm Insulin Pumps
Below is an item that appeared in yesterday’s FDA’s enforcement report. The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
Medtronic MiniMed Paradigm Insulin Infusion Pumps for the following Paradigm models: MMT-511, MMT-512, MMT-712, MMT-515, MMT-715, MMT-522 and MMT-722, Recall # Z-1007-2007
All serial numbers for the following Paradigm models: MMT-51 1, MMT-512, MMT-712, MMT-515, MMT-715, MMT-522 and MMT-722
Medtronic MiniMed, Northridge, CA, by letters on April 24, 2007. Firm initiated recall is ongoing.
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.
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Internationally
Diabetic Investor called MiniMed’s customer service department to ask about the recall and was surprised the representative was unaware of the recall. After reading the notice from the FDA to the representative he indicated that yes there was an issue and that a letter was sent out to MiniMed customers back in April. The representative explained that a pump may malfunction should it come in close contact with Magnetic Resonance Imaging equipment. He further stated that this issue is addressed in the manual and that if customers did not read the manual “cover to cover” they may have been unaware this situation could occur. According to the representative if a customer using a Paradigm pump had come in contact with an MRI or felt uncomfortable with their pump they could run a simple test to determine if their pump was affected by this issue. He went on to state the company would replace the pump if it was under warranty. In the case of an out of warranty pump the customer would be given a loaner pump for 90 days, be contacted by a MiniMed sales representative who would assist the customer in participating in MiniMed’s upgrade program. It was unclear if the customer of an out of warranty pump would be responsible for the cost of the upgrade.
Diabetic Investor also contacted the FDA’s press office to ask why it took so long for the FDA to post this information on their web site (note that according to the notice MiniMed indicates letters were sent out back on April 24th) the spokeswoman indicated that the FDA needed time to investigate so they could classify the recall. This particular recall falls into the Class II category. According to the FDA’s web site:
“A Class II recall usually represents a less serious risk than a Class I recall. In a Class II recall, there is either a possibility that the device will cause temporary or reversible health problems, or there is a remote chance that the device will cause serious health problems.
In a Class II recall, the company notifies their customers (i.e. distributors or vendors) and sometimes asks them to notify the intended recipients of the device. FDA generally does not issue a press release or expect the company to issue a press release for Class II recalls, unless there is a specific need to do so (for example, if the device could affect the health of a large number of people, if patients need more information, or if the recalling company could not reach every intended recipient).”
Based on the most recent statistics from the Radiological Society of North America there were 24.2 million MRI procedures in 2003 and the number has been increasing each year. Keep in mind this not the number of people who had MRI’s rather number of procedures, still with over 24 million procedures performed it’s fair to state that the number of people is sizable.
Diabetic Investor sees this situation as another FDA miscue. While we understand the FDA needs time to investigate it should not have taken over two months to make this situation public. Diabetic Investor further questions the agency’s decision to mark this as a Class II recall, severe hypoglycemia is a life threatening situation. We’re also disappointed that Medtronic (NYSE:MDT) while not intentionally misleading anyone chose to downplay the situation. In our eyes this event is material and should have been disclosed by the company. Besides the cost to replace pumps the company could be facing future liabilities from customer lawsuits. Diabetic Investor is not aware of any such lawsuits still this is America where suing has become a national pastime. Finally, we find it strange that this information has remained unknown until now. As the notice from the FDA indicates there are over 300,000 Paradigm pumps in use worldwide, one would think insulin pump patients who are quite active would be spreading word of this over the internet.
The bottom line here is the FDA has once again failed to properly inform the public of a potentially serious problem with a widely used medical device.