Omnipod DASH Personal Diabetes Manager (PDM)

Insulet Australia Pty Ltd has received reports of problems with the Omnipod DASH Personal Diabetes Manager (PDM). These include battery swelling, fluid leaking from the battery and in rare cases, extreme overheating which may pose a fire hazard.

The potential harms are burns, exposure to toxins and delay in a patient’s insulin therapy.

Omnipod DASH PDMs are not being removed (or recalled) from the market.

Which products are affected?

All Omnipod DASH PDM units with the following part number, reference numbers and UDI may have these problems.

What do I need to do?

• Check if your Omnipod DASH PDM has one of the numbers listed above.
  If it does:
  • Check the back cover. You may need to remove the PDM gel skin to see it clearly.
    • Is it bulging and not closing properly?

Do not apply pressure to the back cover if it is deformed in any way

• Check your PDM while it is charging. Does it:
  • get very hot?
  • smell?
  • not turn on within 45 minutes of being connected to the charger?
  • turn off immediately after being removed from the charger?

• Does your PDM smell when it’s in storage or when you are using it?

If the answer to any of these questions is ‘yes’, you must –

• STOP using the system
• NOT charge the Omnipod DASH PDM

Switch to your backup insulin plan as recommended by your Health Care Professional as soon as possible and contact Insulet’s customer care team on 1800 954 074 or 02 7208 4352 to request a temporary replacement device.

What if my PDM seems ok now?

You can continue to use your Omnipod DASH PDM if you do not experience any of these problems.

Always inspect your Omnipod DASH PDM before charging. To do this, carefully remove the gel skin and check for any deformity such as the back cover bulging, battery leakage, signs of damage at the charging port or difficulty closing the back cover.

To minimise the risk of PDM battery problems, do NOT:

• remove the battery for any reason, even if the User Guide recommends it for troubleshooting. Contact Insulet’s customer care team for further information if you need it.
• continue charging after the PDM reaches 85% of charge.  This means you should not charge your device overnight and you should monitor the device while charging.
• use your PDM while it is charging.

Do NOT charge your PDM:

• if the room temperature is 31°C or higher.
• in direct sunlight.
• when it feels unusually warm to the touch.

How will the problem be fixed?

Insulet will be implementing a software change to update the PDM to limit the charging capacity to reduce the risk of overcharging. Insulet expects your updated Omnipod DASH PDM to be available by June 2023.

You do not need to call to receive an updated Omnipod DASH PDM. One will automatically be shipped to you when it is available.

After you receive the replacement, you can dispose the old device according to local regulations or for direct drop off locations’ information, visit the Australian Government Department of Climate Change, Energy, the Environment and Water webpage on How to Recycle E-waste

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.