Medical Device Correction - November 2023

December 7, 2023

An update to the Omnipod 5 App on your compatible Android smartphone* (v1.2.4) is now available. The software update will fix the issue discussed in the recent Medical Device Correction (REF: 9056196-11/22/2023-001-C) pertaining to the bolus calculator.

Upon updating your Omnipod 5 App software to v1.2.4 this issue is resolved. It is still important that you confirm the bolus amount is what you desire before pressing START.

As a reminder the Medical Device Correction does NOT affect the Insulet-provided Omnipod 5 Controllers in the United States.

Completing the Update

You will receive a notification from Google Play (if enabled) or via the Omnipod 5 App. You can also download the update directly on the Google Play Store app listing.

You do not need to be connected to Wi-Fi to receive the Omnipod 5 App update. However, if you have poor cellular service, you may be prompted to connect to Wi-Fi.

Your compatible smartphone can be charging during the Omnipod® 5 App update. Your smartphone must reach the required battery level of greater than 15% before the Omnipod® 5 App will update.

The Omnipod 5 App update will not impact insulin delivery settings or your adaptivity from the algorithm. Normal use of the System will resume upon completion of the update from your compatible device. Do not uninstall and reinstall the App or you will lose your insulin settings and adaptivity from the algorithm.

Support at every step

Have questions about updating your Omnipod 5 App on your Android compatible smartphone? Check out the Phone Control FAQ section on our website.

For additional support or if you have any questions regarding the Medical Device Correction, please contact our Customer Care team at 800-591-3455. We're available 24 hours a day, 7 days a week.

Sincerely,

Your Omnipod Team

*For a list of compatible smartphone devices visit omnipod.com/compatibility.

November 30, 2023

Affected Product:  
 

Please read this notice in its entirety.

Dear Valued Customer,

You are receiving this letter as our records indicate that you are a user of the Omnipod® 5 App from Google Play on your compatible Android smartphone. The app is part of the Omnipod 5 Automated Insulin Delivery System. This notice is a voluntary Medical Device Correction related to an issue with the Omnipod 5 App bolus calculator. Insulet has received 2 reports of adverse events related to this issue.

This does NOT affect the Insulet-provided Omnipod 5 Controllers. The Insulet-provided Omnipod 5 Controllers are operating on software version 1.0.91 and do not have this issue.

This does NOT affect the Omnipod 5 Pods, the Omnipod DASH® Insulin Management System, or the Omnipod® Insulin Management System.

What devices are affected?

This affects the Omnipod 5 App from Google Play on your compatible Android smartphone.

What is the issue?

We have received reports from Omnipod 5 smartphone app users where the bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. If the user does not recognize the issue, this may lead to delivery of more insulin than intended, which can lead to severe hypoglycemia.

This issue only occurs if:

• You use the bolus calculator to calculate a bolus dose or enter a bolus amount into the Total Bolus box at the bottom of the screen, AND
• You tap the Total Bolus box to change the bolus amount to a value less than 1 unit (1 U), starting with a decimal point (e.g., .3 U) when the decimal fails to register, AND
• You do not recognize that the bolus amount is wrong and start the bolus that is larger than you intended (e.g., 3 U instead of 0.3 U).

Once the bolus dose is confirmed and you tap START, the value that is shown on the screen will be delivered by the system.

How do you avoid giving the wrong bolus amount?

1. When changing a bolus dose to less than 1 unit, always enter a zero (0) before the decimal (e.g., enter 0.3 instead of .3) (Figure 1)
2. Always check the bolus amount shown in the Total Bolus box before tapping CONFIRM
3. Double-check the amount on the Confirm Bolus screen (Figure 2) to make sure this is the amount you want to deliver before pressing START to deliver the bolus
4. Check the amount again while the bolus is in progress on the Delivering Bolus screen (Figure 3)

As stated in our User Guide, it is important to review the bolus amount before you confirm and start the bolus. The Omnipod 5 App will always deliver the amount you confirm and that is shown on the Confirm Bolus screen (Figure 2). This amount can also be checked while the bolus is in progress on the Delivering Bolus screen (Figure 3). If it’s not the amount you expected, you can always CANCEL the bolus. To check how much insulin has been delivered, check the Last Bolus box on the home screen or your History Detail.