Medical Device Correction Investor FAQs

Feb 13, 2020

Medical Device Correction Investor FAQs

Does this mean you will replace all the current Omnipod DASH™ PDMs in the field?

  • A software update is being developed to provide a solution for this issue and is expected to be available starting March 2020.
  • We will provide new PDMs containing the software update to all Omnipod DASH™ users and we will contact them directly when we are ready to ship.
  • From extensive testing and analysis, the likelihood of this sequence of events occurring is considered very low.

What is the potential impact and when will this happen?

  • As noted above

How was this discovered and how quickly can you rectify the situation?

  • Customer safety is Insulet’s top priority.
  • The situation with the Omnipod DASH™ System Bolus Calculator was identified through Insulet’s ongoing product quality monitoring process.
  • It is important to note that no injuries have been reported.
  • A software update is being developed to provide a solution for this issue and is expected to be available starting in March 2020.
  • We will provide new PDMs containing the software update to all Omnipod DASH™ users and we will contact them directly when we are ready to ship.

How does this potentially impact your Horizon clinical trials and timing of launch?

  • This Medical Device Correction is specific to the Omnipod DASH™ PDM and does not impact any other products.

Are you delaying rolling out DASH in Europe or will you move forward as planned?

  • Insulet will maintain ongoing distribution of the Omnipod DASH™ System in the UK, Netherlands, and Italy.
  • Launching the Omnipod DASH™ System in additional EU markets will continue throughout the year with the updated Omnipod DASH™ PDM software.

Does it call into question entering the new countries you stated you plan to enter?

  • There is no change to Insulet’s publicly stated market expansion plans.

Will this Medical Device Correction have an impact on Insulet’s financials?

  • The Medical Device Correction is not expected to have a material impact on Insulet’s 2019 financial results.

For additional information, please see the consumer FAQs at: https://www.myomnipod.com/dash-pdm-correction.