Even More On The MiniMed Recall – Is there a design flaw withParadigm pump?

Even More On The MiniMed Recall – Is there a design flaw withParadigm pump?

Diabetic Investor has been searching for an answer as to why Medtronic (NYSE:MDT) is doing their best to minimize the Class II recall of Paradigm insulin pumps. If as the companies claims Paradigm patients can run a simple test to check if their pump has been affected why is it that so few Paradigm patients and the their physicians are aware of the recall. Could it be there is a design flaw with the Paradigm pump and that the company does not wish to incur the financial burden of replacing or fixing this flaw?

According to the recall it’s possible that when a Paradigm pump comes in contact with a MRI, X-ray, CT Scan or exposure to other types of radiation the pump may malfunction and deliver too much insulin which could lead to severe hypoglycemia, a serious and potentially life threatening event. The question is why didn’t the company build in a fail safe system that would automatically shut down the pump when it violates pre-programmed insulin delivery rates? Diabetic Investor has spoken with several engineers who believe a fail safe could be easily programmed into the pump and avoid the delivery of too much insulin.

For those unfamiliar with insulin pump therapy, pumps do not arbitrarily deliver insulin, the patient programs the pump telling it how much insulin to deliver. Even when a patient eats and calculates how much additional insulin they need to cover their meal intact they must confirm the amount of insulin before it is delivered. The reality of the situation is pumps should only do what they are told and whenever performance operates outside pre-programmed parameters the pump should shut down.

Given that so many people were unaware of the recall and 5 adverse events specifically related to this issue were recorded after the letter was sent, this is a serious issue that demands greater attention. Medtronic has a moral obligation to make every reasonable attempt to contact all patients, physicians, educators, distributors and pump trainers in regards to the recall. Up until know Diabetic Investor could not see any reason why the company did not do so. The only reasonable explanation is there is a deeper problem here.

David Kliff
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