MiniMed Recall – The more we dig the worse it gets
Searching through the FDA’s MAUDE database there were 29 deaths reported for patients using a MiniMed insulin pump. Although all 29 reports did not come with detailed explanations, 7 of the 29 specifically mentioned hypoglycemia or systems of severe hypoglycemia such as a coma or seizures. That means 24% of the deaths were associated with hypoglycemia – an event that FDA does not consider a serious risk. Diabetic Investor doubts the families of the 7 MiniMed patients who passed away as a result of hypoglycemia would see it that way.
Our search also discovered two more adverse event reports that specifically mention MRI. Both were from the 500 series one on 5/1/2007, the other on 5/2/2007- again well after the date when MiniMed said they sent out letters warning patients of this issue. This brings the total number of adverse event reports that specifically mention MRI or X-ray up to 9, 7 of which occurred weeks after MiniMed sent out letters warning patients of this issue.
Not surprisingly Diabetic Investor has yet to hear from the company about the possibility that the Paradigm line of pumps contain a design flaw. As the adverse event reports clearly indicate this is a serious problem that demands attention. Is it possible the reason Medtronic (NYSE:MDT) is doing their best to low key this recall is because they are concerned the FDA may reconsider their original decision to classify this recall as a Class II recall and make it a Class I recall which would require the company to replace the pumps.
According to the recall there are 334,000 Paradigm pumps in circulation. Assuming it costs approximately $800 to manufacturer each pump replacing all 334,000 pumps would cost over $267 million, not to mention the potential liability the company would face from the lawsuits that would surly follow. While Diabetic Investor is not an expert when it comes to regulation FD, we believe this would qualify as a material event that would require at least a press release.
Diabetic Investor continues to look into this issue as the more we dig the more questions and concerns come to light. Once again it appears the FDA has failed to protect the public from what clearly is a serious problem. It’s equally clear that Medtronic has failed to fulfill their responsibility to make every attempt to inform their patient base of this issue. The fact is every insulin pump should be built with a fail safe system that prevents the over-infusion of insulin, even if the FDA does not consider death a serious health risk.