Urgent: field safety notification

Urgent Information Regarding the Omnipod DASH® Insulin Management System Bolus Calculator

FSCA REF. 9056196-02/07/2020-001-C

Affected Product:

Device Description: Omnipod DASH® Personal Diabetes Manager (PDM)

Software Version: Version 1.0.1

Dear Valued Customer,

You are receiving this letter as our records indicate that you are a current user of the Omnipod DASH® System. As the manufacturer of the Omnipod DASH® System, customer safety is Insulet International’s top priority. In line with this, we are writing to you with important safety information regarding the Omnipod DASH® System’s Bolus Calculator. It has come to our attention that in certain scenarios described below, there is a remote possibility that the Omnipod DASH® PDM (Personal Diabetes Manager) may suggest an insulin bolus amount based on incorrect information. If the user is not aware of this issue and delivers the bolus, it may result in over- or under-delivery of insulin, which may lead to hypoglycaemia or hyperglycaemia.

This does NOT affect the Omnipod DASH® Pods or the widely distributed Omnipod^® Insulin Management System. This notice is being issued as a precautionary measure. It is important to note that no injuries have been reported.

A software update is being developed to provide a solution for this issue, which is expected to be available from August 2020. We will provide new PDMs containing the software update to all Omnipod DASH® users and will contact you when we are ready to ship your PDM.

What is the expected experience with the Omnipod DASH® PDM Bolus Calculator?

In the Omnipod DASH® PDM, the Bolus Calculator feature can be used to calculate a meal and/or correction bolus. The Bolus Calculator factors in the grams of carbohydrates entered, the user’s current blood glucose (BG) value, and the user’s insulin on board (IOB) to suggest a bolus amount. If the BG value is older than 10 minutes when the user tries to initiate a bolus, the Omnipod DASH® PDM should prevent this bolus from being delivered (see Figure 1 below).

Figure 1: The timestamp associated with the BG value was greater than 10 minutes old, therefore the Omnipod DASH™ PDM does not allow the user to select Confirm at the bottom right of the Bolus Calculator screen to deliver the bolus.

How could the Bolus Calculator not function as intended?

On rare occasions, the bolus calculator may use an old BG value that was entered more than 10 minutes prior and suggest an inaccurate bolus amount to the users. There are two specific scenarios where this may occur:

Scenario 1:

A user enters a BG value into the Bolus Calculator and does not deliver a bolus (Figure 2).
The user selects “Cancel” at the bottom of the Bolus Calculator screen.
After selecting “Cancel”, a prompt asks the user “Are you sure you want to cancel?” with the options“Yes” or “No” (Figure 3).
If the user does not choose either option after 10 minutes, and the Omnipod DASH™ PDM screen isput to sleep or the screen times out, this old BG value will be used in the next bolus calculation.
The next time the user enters the Bolus Calculator, they are presented a screen (Figure 4) which cansuggest an inaccurate bolus amount. The Total Bolus is calculated based on the old BG value, eventhough no BG is displayed on the screen.
If the user selects “Calculations”, the old BG reading is displayed for the correction bolus (Figure 5).
The suggested dose may be too much or too little for the user, and if delivered by the user, may resultin either hypoglycaemia or hyperglycaemia.

Note: The Figures above are for illustration purposes only. Actual values will vary based on user input.

How do you prevent the user from giving an inaccurate bolus?

Always follow instructions on the Omnipod DASH™ PDM screen. In Scenario 1, selecting “Yes” or“No” when prompted to confirm the cancelled bolus will prevent this situation.
Always enter a current BG into the Bolus Calculator before giving a bolus. This will replace the old BGvalue and ensure an accurate dose is calculated based on the current BG.
Always check the “Calculations” before initiating the bolus. The Total Bolus should always be the sumof the Meal Bolus and Correction Bolus.

Scenario 2:

A user enters a BG value into the Bolus Calculator.
Before initiating the bolus, an alarm occurs on the Omnipod DASHTM PDM or Pod that forces the user to deactivate their current Pod. See example alarm in Figure 6.
When the user activates a new Pod, the previously entered BG value will be used in the next bolus calculation.
The next time the user enters the Bolus Calculator, they are presented a screen (Figure 7) which can suggest an inaccurate bolus amount. The Total Bolus is calculated based on the old BG value, even though no BG is displayed on the screen.
If the user selects “Calculations”, the old BG reading is displayed for the correction bolus (Figure 8).
The suggested dose may be too much or too little for the user, and if delivered by the user, may result in either hypoglycaemia or hyperglycaemia.

Note: The Figures above are for illustration purposes only. Actual values will vary based on user input.

How do you prevent the user from giving an inaccurate bolus?

Always enter a current BG into the Bolus Calculator before giving a bolus. This will replace the old BG value and ensure an accurate dose is calculated based on the current BG.
Always check the “Calculations” before initiating the bolus. The Total Bolus should always be the sum of the Meal Bolus and Correction Bolus.

How did Insulet become aware of this Bolus Calculator issue?

Insulet is currently aware of 11 complaints associated with this issue in the United States and there have been no reports of injury. If a user is unaware of this issue, the incorrect information may result in over- or under-delivery of insulin, which may lead to hypoglycaemia or hyperglycaemia. For this reason, this notice has been issued to help users identify and avoid the issue.

What devices are affected?

This notice affects the Omnipod DASH™ PDM (using software version 1.0.01 and earlier). Users can check their Omnipod DASH™ PDM’s software version on the “About” screen in the Omnipod DASH™ PDM menu.

Is it safe for users to continue using the Omnipod DASH™ PDM?

Yes, it is safe for users to continue using the Omnipod DASH™ PDM if the steps detailed above are followed to ensure incorrect information is not used to calculate the suggested bolus. This action taken by Insulet International is voluntary. All affected National Competent Authorities have been made aware of this potential situation through the appropriate Vigilance reporting processes.

How do I request a replacement PDM?

A software update is being made to the next version of the Omnipod DASH™ PDM which will provide a solution for this issue and is expected to be available from August 2020. We are voluntarily providing a replacement PDM to all Omnipod DASH™ users and we are contacting users directly via email or letter to arrange for a replacement PDM to be shipped when one is available.

If you have received an email from Insulet providing you with the information covered in this letter and you have already responded to provide your details to us, you do not need to do anything more at this time.

If you have not received an email, we would ask that you go our website www.omnipod.com/en-gb/dash-correction to confirm receipt of this letter and provide the Serial Number of your Omnipod DASH™ PDM to ensure a replacement is reserved for you.

You can also visit our website www.omnipod.com for updated information on the PDM replacement timing. In the meantime, you may continue using your current Omnipod DASH™ PDM provided you follow the steps detailed above to ensure incorrect information is not used to calculate the suggested amount of insulin to deliver.

If you have any questions regarding the information provided or you’d prefer to confirm receipt of this communication over the phone please contact Customer Care on 0800 011 6132 (+44 (0) 203 887 1709 when calling from abroad) or email [email protected].