The Medicines and Healthcare products Regulatory Agency (MHRA) have issued a warning about problem software with the Omnipod DASH™ PDM (Personal Diabetes Manager).
In certain scenarios there is a remote possibility that the Omnipod DASH™ PDM (Personal Diabetes Manager) may suggest an insulin bolus amount based on incorrect information. If the user is not aware of this issue and delivers the bolus, it may result in over- or under-delivery of insulin, which may lead to hypoglycaemia or hyperglycaemia.
Omnipod DASH™ Pods or the widely distributed Omnipod® Insulin Management System are not affected.
A software update is being developed to provide a solution for this issue, which is expected to be available from April 2020.
You can read the Field Safety Notice from Healthlink Europe/Omnipod for more information.