PRA number
Published date
Product description
Omnipod DASH Personal Diabetes Manager (PDM)
All serial numbers
ARTG 344290
(INSULET AUSTRALIA PTY LTD - Ambulatory insulin infusion administration unit/remote control system - Ambulatory insulin infusion administration unit/remote control system)
The Omnipod DASH PDM is an Android mobile device used to control each Omnipod DASH system. It is used to activate/deactivate Pods, display alerts/alarms, and send insulin delivery commands for execution to the Pod.
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Reasons the product is recalled
The product's battery pack may swell, leak fluid or overheat and could catch on fire.
The hazards to consumers
If the battery overheats, this could result in a fire which can cause serious injury or death.
Additionally If the PDM becomes inoperable there may be a delay in therapy. If insulin delivery is suspended, this may lead to major hyperglycemia which can result in serious health complications. In severe cases of hyperglycemia, the user may experience diabetic ketoacidosis and may require hospitalisation or intervention from a medical professional.
What consumers should do
Insulet Corporation is implementing a software change to the PDM to limit the charging capacity to mitigate the risk of overcharging. An updated Omnipod DASH PDM will be provided to affected consumers when available.
Do not charge the PDM if:
i) The PDM battery compartment is bulging.
ii) The PDM experiences overheating.
iii) The PDM does not turn on within 45 minutes of being connected to the charger or turns off immediately after removing from the charger.
The PDM can be continued to be used with caution if consumers do not experience the above issues:
i) Do not remove the battery from the PDM for any reason.
ii) Do not continue charging after reaching 85% of charge. Do not charge the device overnight.
iii) Do not charge PDM if surrounding temperature is 31 degree C or higher. Do not charge under direct sunlight.
iv) Do not charge the PDM when it feels unusually warm.
v) Do not use PDM while charging.
vi) Always inspect PDM before charging.
For more details, see https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01321-1
For further information, please contact Insulet Australia Customer Care on 1800 954 074.
Supplier
Where the product was sold
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.