Medical Device Correction - November 2023
November 30, 2023
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URGENT: Medical Device Correction
REF: 9056196-11/22/2023-001-C
Urgent Information Regarding the Omnipod® 5 Automated Insulin Delivery System
Affected Product:
| Device Description | Software Version | UDI |
|---|---|---|
| Omnipod® 5 App (on compatible Android smartphones) | ALL active smartphone apps are affected. (Versions 1.1.0 – 1.2.3) | 1038508112030 |
Please read this notice in its entirety and acknowledge receipt and understanding of this notice by clicking the Acknowledge button above.
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?
- 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)
- Always check the bolus amount shown in the Total Bolus box before tapping CONFIRM
- 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
- 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.
Figure 1
Figure 2
Figure 3
Is it safe to continue using the Omnipod 5 App?
Yes, it is safe for users to continue using the Omnipod 5 App. If you confirm the bolus amount is the amount of insulin you want to deliver, the system will always deliver this amount. Follow the steps detailed above to ensure that, for values under 1 unit (1 U), the decimal point is registered. This voluntary action is being taken by Insulet with the knowledge of the U.S. Food and Drug Administration (FDA). Adverse reactions or quality problems experienced with the use of this product should be reported to the FDA’s MedWatch Adverse Event Reporting program either at www.fda.gov/Safety/MedWatch or by regular mail or by fax.
When will the issue be fixed?
We are working diligently to correct this issue and expect a software update as soon as possible. We will inform you via email and update our website when available. Once available, the update will be pushed to your device. You will not lose settings or history because of the update.
We understand this may impact your experience and are here to support you. If you have any questions regarding the information provided in this Medical Device Correction, please refer to the FAQs below or please call 800-591-3455 to speak with a member of the Insulet Customer Care team who are available 24 hours a day, 7 days a week.
We are grateful for our Podders who communicated their experience with this issue.
Sincerely,
Laetitia Cousin
Senior Vice President, Regulatory Affairs, Quality Assurance, and Compliance
Insulet Corporation
Frequently Asked Questions
I believe my Omnipod 5 App is experiencing this issue outlined in the safety communication, what should I do?
Is the Omnipod 5 System safe to use?
Does this issue impact any other Omnipod® products?
How do you avoid giving the wrong bolus amount?
Does this impact all Omnipod 5 Users?
When will the fix be made to the Omnipod 5 App and how do I get it?
I was thinking about purchasing a compatible phone and downloading the Omnipod 5 App. Should I wait?
How do I know if my Omnipod 5 app is impacted by the issue outlined in the safety notification?
Can I revert back to using the Omnipod 5 Controller?