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?
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.