OmniPod 5 - Potential Risks

Introduction 1
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1 Introduction
Caution: DO NOT navigate away from the Omnipod 5 App while you are in the
process of making changes to your insulin delivery settings. If you leave the App
before you are able to save the setting change and before the App is able to put the
setting change into eect, the system will continue to use your last saved settings.
As a result, you may continue with therapy settings that you did not intend. If you
are unsure about whether your changes were saved, review your settings.
Caution: AVOID leaving your Controller in a place that would prevent you from
hearing alarms and notications from your Omnipod 5 App. Delivery of insulin
in Manual Mode or Automated Mode continues as programmed if you move
away from your Controller.
Caution: ALWAYS respond to Pod Expired, Low Pod Insulin, and Pod Shutdown
Advisory Alarms when they occur. ese alarms escalate to Hazard Alarms if no
action is taken. When Hazard Alarms occur, insulin delivery stops.
Caution: ALWAYS be aware of possible changes to your time zone when
travelling. If you do not update your time zone, your insulin therapy will be
delivered based on your old time zone, which may cause disruptions in your
insulin delivery schedule and inaccurate history logs. Talk to your healthcare
provider about how to manage your insulin delivery while travelling between time
zones.
Caution: You cannot use the Dexcom G6 receiver with the Omnipod 5 System
because the Omnipod 5 System is only compatible with the G6 app on a
smartphone.
Caution: ALWAYS check your glucose frequently during amusement park
rides and ying, or other situations where sudden changes or extremes of air
pressure, altitude or gravity may occur. ough the Omnipod 5 System is safe to
use at atmospheric pressures typically found in aeroplane cabins during ight,
the atmospheric pressure in an aeroplane cabin can change during ight, which
may aect the Pod's insulin delivery. Rapid changes in altitude and gravity, such
as those typically found on amusement park rides or ight take-o and landing,
can aect insulin delivery, leading to possible hypoglycaemia or injury. If needed,
follow your healthcare provider's treatment instructions.
Potential Risks
• e Omnipod 5 System uses sensor glucose values and trends to calculate
insulin delivery. If the sensor glucose values are inaccurate, the System could
deliver an inaccurate dose of insulin, which can lead to hypoglycaemia or
hyperglycaemia.
• e Omnipod 5 System uses the information and settings that you enter
to calculate and adjust insulin delivery. If the information you enter is
inaccurate, or if you don’t give the System information about carbs and
glucose, the System could deliver an inaccurate dose of insulin, which can
lead to hypoglycaemia or hyperglycaemia.