Swedish Court Allows Medtronic to Continue Sales of Insulin Pump

A Swedish court has put temporary brakes on an order from the country’s Medical Products Agency that would require Medtronic to halt sales and recall its MiniMed 640G insulin pump. The stay will remain in place as Medtronic appeals the regulator’s actions before another court.

The decision by the Administrative Court of Appeal in Stockholm comes about two months after the company informed patients, healthcare providers and regulators in EU countries and Australia there was an issue with the Minimed 640G pumps that affected the bolus screen. The screen would not always timeout, possibly creating confusion by showing an older, inaccurate bolus amount.

Medtronic did not remove the pump from the market, but sent a notice to users and healthcare professionals with updated and clarified instructions on how to avoid the problem.

The MPA ordered Medtronic to stop sales of the product and instruct users not to use the Bolus Wizard feature or recall the device. It based its decision on an assessment that the product’s software has flaws.

The Stockholm court made its decision based on testimony from medical experts who provided a statement to the court questioning the regulator’s decision.

The group said there is a greater risk of withdrawing the devices, and that there is a group of patients in Sweden that benefits from having a feature on the pump that prevents too low blood sugar levels. A court in Uppsala is listening to Medtronic’s appeal of the MPA’s decision.

The MPA is asking healthcare professionals to report adverse events and near misses to Medtronic and the agency.

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