Another Medtronic Recall
This morning Medtronic (NYSE:MDT) began yet another recall involving their insulin pump products. This time the problem involves their Quick-Set® infusion sets. According to an email that has been sent to Medtronic patients “We took this action because of a situation related to the tubing connector. We estimate that approximately 2% of the infusion sets (which represents approximately 60,000 infusion sets out of an estimated 3 million infusion sets currently with customers) may not allow the insulin pump to vent properly. Venting is necessary to equalize the pressure in the reservoir compartment with the surrounding atmosphere. If the vent does not work properly, this could potentially result in too much or too little insulin being delivered and may lead to serious injury or death.”
The email also contains a link to web site the company has set up where patients can get more information. The only problem is the link doesn’t work. When Diabetic Investor called the company they stated the link isn’t working because the site won’t be operational until tomorrow. The company could not provide an explanation as to why the emails were sent out before the site was operational.
The email is also signed by Francine R. Kaufman, M.D., Chief Medical Officer and Vice President, Global Medical, Clinical & Health Affairs Medtronic Diabetes and Chris O’Connell President, Medtronic Diabetes and states they are available to answer patient questions. This is a highly unusual move for Medtronic who typically relegates any questions to their customer service department.
In typical Medtronic fashion they don’t actually call this a recall but a field action. Which is strange when you actually read the email it states “Medtronic Diabetes is voluntarily recalling Quick-set* infusion sets that have lot numbers starting with the number "8" and “For those patients who have not ordered from us this calendar year, we are notifying them of the recall and inquiring if they need replacement infusion sets.”
This recall is just the latest in series of recalls from Medtronic. Diabetic Investor can’t help but wonder if in their vest to cut costs if the company just might be skimping a bit on quality control. As we wrote back on June 25th, 2009 when the company received a warning letter from the FDA which stated “Our investigators determined that a product reporting specialist was making decisions about MDR reportability for the MiniMed Paradigm® Insulin Pumps. The training record for this particular employee showed that this person only had a high school diploma with some additional in-house training.”
One also has to wonder just how a company who can’t seem to get the simple things done correctly will produce and support a complex product like a closed loop insulin delivery system; a system which they themselves see as critical to their future. A true closed loop system has multiple parts which only enhances the chances that something will go wrong. This is one reason Diabetic Investor has never been overly fascinated with a closed loop insulin delivery system. It is also the same reason many respected endocrinologists who are strong supporters of insulin pump therapy don’t see a closed system as major tool for improving patient outcomes. As we have seen by the many recalls machines no matter how well designed and tested fail. While this typically isn’t a huge issue when a closed loop system fails it could lead to disastrous consequences including severe hypoglycemia or death. The simple facts are the more parts there are to a system the more opportunities there are for failure.
Yet Medtronic insists on moving forward with their quest to be the first company to introduce a closed loop insulin delivery system. A system that Diabetic Investor estimates will come with a price tag north of $10,000 and will dramatically increase the company’s liability risk profile. A system that even the most respected supporters of insulin pump therapy have told Diabetic Investor they would not recommend for their pump patients.
Given the number of recalls the company has experienced over the past few years one might think that the company would be better off getting their current house in order before moving onto another piece of sophisticated technology that only a handful of patients will actually use. Medtronic may be wise to remember the words of Goethe who noted; “Everything is simpler than you think and at the same time more complex than you imagine.”
