Medtronic (NYSE:MDT) issued an urgent field safety notice in Germany to warn of a potential issue with its MiniMed 780G system.
MiniMed 780G, Medtronic’s next-generation automated insulin delivery system, has been available in Europe since earning CE mark in mid-2020. In March 2021, the company first communicated that its pumps with software version 6.5 could present pump errors. These occur after the delivery of a large bolus at quick bolus speed under certain conditions.
With its notice, Medtronic informed customers in Germany that they can exchange their current pumps for an updated version for free. Those with MiniMed 780G pumps with software version 6.5 can change to a pump with software version 6.7. This eliminates the potential occurrence of these errors so users can use the pump for boluses over 17.1 units at quick bolus speed.
This issue only impacts customers using pumps with software version 6.5. There is no required action for users of MiniMed 780Gs with software version 6.7.
“We regret any inconvenience this may cause,” Medtronic said in its notice.”We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact our Helpline at 0800/6464633.
About the potential Medtronic MiniMed 780G pump error
The issue may result in errors if all of the following conditions occur: the user has a pump with software version 6.5, the bolus delivery speed is programmed to “Quick,” the SmartGuard feature is in use, the pump is on the bolus delivery screen when an auto-correction bolus is triggered and the bolus amount is programmed to at greater than 17.1 units. Auto-corrections occur when sensor glucose runs high and active insulin runs low.
If all conditions are met, within two minutes of bolus delivery completion, the pump initiates Pump Error 53. The Pump Error 23 alarm follows, then the pump screen displays the error.
Upon clearing the errors, the pump resets and indicates the clearance of active insulin. It then guides the user to resume operation in Manual Mode, Medtronic said. The SmartGuard status screen indicates that the warm-up period started. Since active insulin displays 0.0 units in the pump after the errors, if the user remains unware of the active insulin amount and delivers an additional bolus, there is a risk of over-delivery.
Over-delivery could result in hypoglycemia or severe hypoglycemia. In rare cases, severe hypoglycemia, if left untreated, may lead to a life-threatening situation.