|MiniMed 640G insulin pump with built-in continuous glucose monitoring--Courtesy of Medtronic|
Medtronic ($MDT) disclosed difficulties with almost 2,000 units of its latest model insulin pump, the MiniMed 640G, which had been distributed in 10 European countries, according to a recall notice just issued by the FDA. This model had its European launch in January and is slated for a PMA submission later this year.
The reported problem, which the FDA classified a Class 2 recall--meaning that it can cause reversible adverse health consequences--is that the system does not time out when the screen is set for a bolus insulin delivery. That can cause confusion for patients, because the bolus amount is no longer accurate.
The ability to suspend and then restart insulin delivery levels automatically based on sensor glucose levels is supposed to be the advantage of the MiniMed 640G and marks a step toward an artificial pancreas that can automatically regulate relevant hormones for diabetics.
Medtronic originally sent a letter to its customers notifying them of the inaccurate bolus screen problem on June 19. It has not requested the devices be returned. Rather, customers were advised to respond promptly to bolus screens and to not activate bolus insulin delivery based on a blood glucose value that's more than 12 minutes old. Specifically, the recall notice was for 1,936 units across Australia, Czech Republic, Denmark, Finland, France, Ireland, the Netherlands, Norway, Sweden and the United Kingdom.
Diabetes is a relatively small but fast-growing space for Medtronic, which reported $467 million in revenues from the group last quarter--an increase of 8%. That's better than the 7% overall revenue growth rate for its total of $7.3 billion in revenues.
MiniMed is at the core of the device giant's diabetes push--both the EU adoption of the 640G, as well as preparation for a U.S. regulatory nod. On other fronts in diabetes, last quarter Medtronic partnered with IBM Watson Health and made a minority investment in diabetes connectivity and data player Glooko. It also acquired its first diabetes services company, Diabeter, in April. It also in-licensed the DreaMed algorithm for a next-generation closed-loop system.
- here is the FDA recall notice