Omnipod DASH Personal Diabetes Manager (PDM)
Published 11 November 2022
Product
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.
Why it was recalled
The product's battery pack may swell, leak fluid or overheat and could catch on fire.
Hazard
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.
Source: Product Safety Australia. RecallMatch AU provides a screening summary and is independent of the ACCC.