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Insulet’s Omnipod Dash Personal Diabetes Managers have a glitch

February 13, 2020 By Chris Newmarker

Insulet Ominipod Dash Personal Diabetes Managers
The smartphone-like Personal Diabetes Manager [PDM] is supposed to enable an Omnipod Dash user to conveniently and discreetly communicate with their Podd. [Image courtesy of Insulet]
Insulet (NSDQ:PODD) is issuing a voluntary medical device correction for all of the smartphone-like Personal Diabetes Managers that came with its next-gen Omnipod Dash insulin management system, the company announced today.

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.

 

 

Filed Under: Diabetes, Drug-Device Combinations, Featured, mHealth (Mobile Health), Recalls Tagged With: Insulet, insulin

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About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at cnewmarker@wtwhmedia.com.

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