During its ongoing quality management process, Insulet officials discovered that the PDMs on rare occasions will suggest an inaccurate bolus amount based on a blood glucose value that is more than 10 minutes old. The error takes place when a user does not exit the bolus calculator — as designed — or when a system alarm interrupts a bolus calculation.
An inaccurate bolus is a serious matter because too much insulin can be potentially deadly. Insulet said it has no reports of injuries at this time. It said the Omnipad Dash system is still safe to use.
The Acton, Mass.–based company is sending emails and letters to all affected Omnipod Dash users to warn them about the software bug — with replacement PDMs becoming available next month. The company did not disclose how many PDMs are presently out there.
The Street so far today appears to be reacting positively to how Insulet is handling the problem, with PODD shares up more than 2% to $206.20 apiece at midday trading.
Insulet received FDA 510(k) clearance for the Omnipod Dash in June 2018 and launched the device last year.
