Medtronic issues urgent field safety notification for MiniMed Pro-set; approximately 500 customers in initial limited launch – January 17, 2017

This morning, Medtronic issued an urgent field safety notification for the MiniMed Pro-set with BD’s FlowSmart technology. The one-page letter cites a “higher than expected number of reported complaints related to kinked cannulas and elevated blood glucose levels,” something Adam also experienced in his early “week of launch” test drives (Closer Look, diaTribe) following the initial product introduction in late September. Medtronic told us the set has only been shipped to ~500 customers, and “the majority of users” reported they were pleased and would likely re-order if available. The notification applies to all MiniMed Pro-sets, and we’re glad to see Medtronic will replace sets free of charge – notably, its online store now offers the Quick-set and Silhouette set in Luer Lock configurations, expanding on the Pro-set’s Luer Lock offering (and a negative for other pump companies). On a positive note, the notification encourages watching the set insertion video instructions and using the Quick-serter device, both points we would emphasize as much as possible – Adam’s problems stemmed from problems associated with manual insertion and from not reading the instructions. BD’s November Analyst Meeting expected a full launch of the MiniMed Pro-set in ~January-March, though the companies couldn’t comment today on whether that timing still stands; we might assume it will be pushed back, though BD’s JPM presentation last week did call this a “key launch.” It’s also unclear if this is simply a training and instructions issue, or whether it goes deeper into the set’s design and manufacturing. Medtronic and BD are thoroughly reviewing the limited launch feedback to determine causes and quickly work towards a solution. We’re glad to see the companies opted for a limited launch and are learning from initial users’ feedback – while it would have been a clear negative for the field if this had launched widely, the more common launches these days absolutely do require (from a patient’s perspective) a group of “real-world” customers that bring companies more data than just formal trials alone.

  • This is a reminder that manufacturing, training, and commercializing any new diabetes device is never a given, even for experienced players like BD and Medtronic. It’s impossible to test every facet of a product’s design, manufacturing, and training pre-market, something that will be critical to watch as automated insulin delivery rolls out. Patient expectations are also much higher these days, especially as many have been trained, in the age of the iPhone, to pull devices out of the box and start using them without any instructions. We salute Medtronic and BD for determining a path to get “real world” “in the wild” testing from a small number of patients, iterate, test, get feedback, and go back to work. We also salute BD and Medtronic for their ambition and patient orientation; there was clearly a desire in the marketplace for further improvements in this arena and we thank the companies for working on this front. We’ll look for more specific updates on the companies’ upcoming earnings calls.

-- by Adam Brown and Kelly Close