Software errors lead to major insulin pump recall—manufacturer shares a fix
Patients who use the MiniMed 780G insulin pump may need to update its software right away. Medtronic had to recall a total of 26,851 of the popular insulin pumps after identifying three different software defects that needed to be corrected.
The good news, however, is that no devices need to be returned or replaced. By updating the software—as well as updating the MiniMed Mobile app—the three issues should be addressed going forward.
Reviewing the three software defects
On Jan. 30, Medtronic alerted customers that certain MiniMed 780G Insulin Pumps running on software version 6.60 or 6.61 were experiencing two significant issues. First, a pump error was creating confusion about insulin delivery. Second, there was a risk of the Blood Glucose Check feature not performing certain verification/performance checks.
Less than one month later, the company shared another alert highlighting an issue with software version 6.62: A critical pump error was occurring that could potentially stop insulin delivery.
The U.S. Food and Drug Administration (FDA) reviewed these issues and categorized them as a Class II recall. This means using the devices “may cause temporary or medically reversible adverse health consequences” if the recommended corrective steps are not taken.
What patients should do
Any insulin pumps running on software version 6.60 or 6.61 should be updated to version 6.62. In addition, the MiniMed Mobile app should be updated.
Finally, any patients wearing an Instinct sensor when their software is updated to version 6.62 should immediately restart that sensor. If they have already updated the software to version 6.62, on the other hand, they are advised to unpair and then repair the sensor to ensure “uninterrupted therapy.”
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It is worth noting that these issues were identified before Medtronic’s diabetes business had officially gone public and started going by the name MiniMed.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.