After Medtronic rolled out the MiniMed 640G overseas, their next target was the US market. That effort now has hit a speed bump, as the FDA has given public notice that Medtronic has issued a recall notice for almost 2,000 of the devices in Europe.
According to a Fierce Medical Devices article, Medtronic released a customer notification letter on June 19th informing device users that there were instances when the bolus screen wouldn’t refresh properly, so the device might continue to show a bolus amount that was no longer accurate or appropriate. The pump manufacturer hasn’t said that returning the device is necessary. Instead, they advised pump users to not base bolus deliveries on any blood glucose reading that is more than 12 minutes old.
But the FDA has put out notice saying that the timeout problem could cause user confusion. They issued a Class 2 recall notice, meaning there could be “reversible adverse health consequences,” according to the news article.
It is worth noting that Medtronic has only released the MiniMed 640G pump, which has the ability to start and stop insulin delivery based on blood glucose readings, in 9 European countries and Australia, and the company has yet to submit the pump for pre-market clearance in the US. It’s unusual for the FDA to issue official notices about medical device failings for devices sold only in other countries.
Medtronic most likely will need to create a permanent fix to the error if it wants to get the MiniMed 640G approved by FDA regulators. It’s not a great first step in the FDA approval process to have your device show problems elsewhere, but it does not represent an insurmountable challenge to FDA approval if the shortcoming is addressed.
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