Medical Device Recall - October 2022

June 15, 2023

Omnipod DASH®Battery Safety Instructions
Some battery safety instructions in your User Guide need to be updated. Refer to this insert for up-to-date instructions about the Omnipod DASH® PDM battery.

On charging:
Chapter 2: Initial PDM Setup: charging the battery
Chapter 11: Taking Care of Your Pod and PDM: charging
Appendix: PDM Specifications: charging temperature

Updated information: Use only the micro USB charger provided by Insulet to charge your PDM. Contact Customer Care if you notice charging is taking too long or the battery is running out too quickly. Do not charge the PDM if the surrounding temperature is above 104°F (40°C). Do not charge the PDM in direct sunlight.

On removing the battery from the PDM:
Chapter 9: Adjusting Settings: battery removal
Chapter 10: Alarms, Notifications, Communication Errors: alarms that cannot be silenced
Chapter 11: Taking Care of Your Pod and PDM:

for long-term storage of the PDM
for exposure to water
for disposal of the battery
if the battery shows deformity, colour change, or is overheating
if you are replacing a battery after first-time set-up

Appendix: if the PDM stops responding during Fastboot Mode

Updated information: Do NOT remove the battery from the Omnipod DASH PDM for any reason, even if the User Guide or PDM screen recommends it for troubleshooting. If you find a situation where removal of the battery is recommended by the User Guide, do not remove the battery, and contact Customer Care.

On battery moisture, heat, or damage:
Chapter 11: Taking Care of Your Pod and PDM:

cleaning the PDM with liquid
if the battery shows deformity, colour change, or is overheating
dropping the battery

Updated information: If the PDM gets wet, or if the PDM is dropped, damaged, swelling, bulging, or overheats while charging, during use, or in storage, do not use or charge the PDM. Leave a warm or hot PDM unplugged and idle at room temperature on a metal surface until it cools down.

Contact Customer Care immediately.
Contact Customer Care if you notice the following: charging taking too long, the battery discharging too quickly, the PDM being too hot to touch, swelling of the PDM and/or battery, smell of gas coming from the PDM and/or battery, or the wall charger getting too hot.

10/17/2022

URGENT: Medical Device Recall

Urgent Information Regarding the Omnipod DASH® Insulin Management System

Internal Reference Number: 9056196-10/11/2022-001-C

Affected Product:

Device Description	Part Number	Serial Number
Omnipod DASH® Personal Diabetes Manager (PDM)	PDM-CAN-D001-MM SKT-CAN-D001-MM	All serial numbers

Dear Valued Customer,

You are receiving this letter as our records indicate you are a current or past user of the Omnipod DASH® Insulin Management System. This notice is being communicated as a voluntary Field Safety Notification to provide information about the Omnipod DASH® Personal Diabetes Manager (PDM) battery and instructions to reduce the risk of Omnipod DASH® PDM battery issues. It is important to note that no injuries have been reported to Insulet as a result of these Omnipod DASH® PDM battery issues.

This does NOT affect the Omnipod DASH® Pods or the Omnipod® Insulin Management System.

Issue Description: We have received reports from some Omnipod DASH® users regarding PDM battery issues, including battery swelling, fluid leaking from the battery and in rare cases, extreme overheating which may pose a fire hazard. Our investigation has determined that the Omnipod DASH® PDM is at increased risk if charged to full capacity, in particular, if left to charge for extended periods of time (e.g. overnight). Omnipod DASH® PDMs in use more than 18 months may have an increased likelihood of this issue occurring.

Solution: We have identified an update to the Omnipod DASH® PDM that will address this issue. We expect to begin shipping updated Omnipod DASH® PDMs to all customers in the coming months.

You do not need to call to receive an updated Omnipod DASH® PDM, one will automatically be shipped to you when available.

Until you receive your updated Omnipod DASH® PDM, please follow the actions below:

Actions to Users:

If you experience any of the following issues, do not charge your Omnipod DASH® PDM and promptly contact the Insulet Customer Care team specifically trained to help you at 1-833-433-1595:

The Omnipod DASH® PDM back cover is bulging or cannot close. You may need to remove the PDM gel skin to observe any of these issues. Do not apply pressure to the back cover if it is deformed in any way.
The Omnipod DASH® PDM experiences extreme overheating (uncomfortable to hold) or emits an odor while charging, during use, or in storage.
The Omnipod DASH® PDM does not turn on within 45 minutes of being connected to the charger or turns off immediately after being removed from the charger. If your PDM battery loses its charge very quickly (more than you have previously experienced) or if it takes more than 1.5 hours to reach 80% charge, contact the Insulet Customer Care team.

Continue to use your Omnipod DASH® PDM if you do not experience any of the symptoms listed above and follow the actions below to reduce the risk of PDM battery issues:

Do NOT remove the battery from the Omnipod DASH® PDM for any reason, even if the User Guide recommends it for troubleshooting. If you are in a situation where removal of the battery is recommended by the User Guide or PDM screen message, do not remove the battery and contact the Insulet Customer Care team at 1-833-433-1595.
Do NOT continue charging the Omnipod DASH® PDM after it reaches 85% of charge. This means you should not charge your device overnight and you should monitor the device while charging.
Do NOT charge the PDM if the surrounding temperature is 31°C (87°F) or higher. Do not charge the PDM in direct sunlight.
If the Omnipod DASH PDM® is unusually warm, leave the PDM unplugged and idle at room temperature until it cools down. Do not charge the PDM when it feels unusually warm to the touch.
Do NOT use your Omnipod DASH® PDM while it is charging.
Always inspect your Omnipod DASH® PDM before charging (remove gel skin / cover) for any deformity, back cover bulging, battery leakage, signs of damage at the charging port, or difficulty closing the back cover.

We understand this may impact your experience and are here to support you. We will notify you when we start to ship the updated Omnipod DASH® PDM.

If you have any questions regarding the information provided in this Field Safety Notification, please see the Frequently Asked Questions below or call 1-833-433-1595 to speak with a dedicated staff member of the Insulet Customer Care team.

Sincerely,

Michael Spears
Senior Vice President, Regulatory Affairs & Compliance
Insulet Corporation

Frequently Asked Questions

I believe my Omnipod DASH® PDM is experiencing one or more of the issues outlined in the safety communication, how do I get a replacement?

The safety communication says to stop using the PDM if it is experiencing certain issues. How do I manage my diabetes until I receive my replacement Omnipod DASH® PDM?

Does this issue impact any other Omnipod® products?

Should I change the Omnipod DASH® PDM battery to prevent this issue?

Is it safe to use a different charger?

What can I do to limit these issues from happening?

How much should I charge my Omnipod DASH® PDM?

Should I charge my PDM overnight?

Does this impact all Omnipod DASH® PDMs?

Will Insulet continue to sell Omnipod DASH®?

What should I do if my Omnipod DASH® PDM is functioning normally?

Can this issue affect the performance of the Omnipod DASH® Insulin Delivery System? (i.e. will it deliver inaccurate insulin volume?)

If my PDM is at the recommended maximum 85% charge level, am I able to connect to upload/download my data?

If the PDM is left in direct sunlight and gets very warm, am I able to use my PDM?

What should I do if my PDM has been in use for more than 18 months?