| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-01321-1 |
| Product Name/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) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
31/10/2022 |
| Responsible Entity |
|
| Reason/Issue |
Insulet Corporation has been made aware of events involving Omnipod DASH Personal Diabetes Management (PDM) battery issues, including battery swelling, fluid leaking from the battery, and in rare cases, extreme overheating, which may pose a fire hazard (thermal runaway events).
The thermal event may result in the consumer to be exposed to thermal energy and toxin. The issue may lead to delay in therapy too due to patients' PDM becoming inoperable.
455 customer complaints including 25 adverse events have been reported worldwide with zero reports in Australia to date associated to the issue.
This does NOT affect the Omnipod DASH Pods. |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
Insulet are advising customers:
Do not charge the PDM if:
i) The PDM battery compartment is bulging
ii) The PDM experience extreme 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
Continue to use the PDM with caution if 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 deg 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
Insulet is implementing a software change to the PDM to limit the charging capacity to mitigate the risk of overcharging.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 954 074 - Customer care - Insulet |