Safety Notes – October 2022 FSCA: 9056196-10/11/2022-001-C
Frequently Asked Questions
for the safety note FSCA: 9056196-10/11/2022-001-C
As users of the Omnipod DASH® System we want you to read carefully about the safety notice and then you can read the frequently asked questions and their answers in relation to the directive of the urgent safety directive:
If you are experiencing any of the issues outlined in the safety communication, please contact Insulet Customer Care at 217 000 9999
Please go back to the backup insulin plan that you and your healthcare provider have established.
No, we have only identified this issue in Omnipod DASH® PDMs. This does NOT affect Omnipod DASH® Pods or the Omnipod® Insulin Management System.
Do not open the back cover of the Omnipod DASH® PDM or replace the battery and please follow the instructions in the safety notice.
The Omnipod DASH® PDM should only be charged with the Insulet provided charging base and cable. If you have misplaced the charging cable or base, please contact 217 000 9999 for a replacement.
The recommendation is to not charge your Omnipod DASH® PDM past 85% of charge, do not charge the PDM in surrounding temperatures of 31C / 87F or higher, do not leave it charging overnight, and to stop charging it if it feels too warm to touch.
Please discontinue charging the Omnipod DASH® PDM once it reaches 85% of charge. You should also not charge your device overnight and you should monitor the device while charging.
No, do not charge the Omnipod DASH® PDM overnight.
Yes, this impacts all Omnipod DASH® PDMs.
Yes, Omnipod DASH® is still a safe and effective insulin delivery system.
You can continue to use the Omnipod DASH® PDM but we ask that you please follow the instructions outlined in the safety notice. We have identified an update to the Omnipod DASH® PDM that will address this issue. We expect to begin shipping updated Omnipod DASH® PDMs to all customers in the coming months free of charge.
No, this issue does not affect the performance of the Omnipod DASH® System. Omnipod DASH® is still a safe and effective insulin delivery system.
Yes, you can continue to connect to a Laptop or PC to download data and then disconnect when completed.
If the PDM feels warmer than the surrounding temperature after being left in direct sunlight, please let the PDM cool down prior to use.
If your PDM is showing any issues outlined in the safety communication, please call Insulet Customer Care. If your PDM has been in use for more than 18 months and it is working normally, it is safe to continue using.