2 days ago I got an email from Tandem about the Mobile Tandem Connect app. I had noticed that the graphics would be blank and then I thought my nearly 3 year old pump was having battery issues. In the past I would charge when I changed cartridges, with battery never below 50%. Now I might lose 60% in one day.
Here’s the text of the email:
UPDATE TO URGENT MEDICAL DEVICE CORRECTION
Mobile App v2.7 Crashing Resulting in Pump Battery Depletion
Additional Actions Requested
FDA Recall Number: Z-1609-2024 (RES# 94312)
August 9, 2024
On March 26, 2024, Tandem Diabetes Care issued an "Urgent Medical Device Recall” notification, which was classified as Class I by the FDA. It has come to our attention that users may still be experiencing occurrences of pump battery depletion after updating their t:connect mobile app to version 2.7.1.
Tandem is providing this updated recall notification because our records indicate that you may be operating the t:connect® mobile app on the Apple iOS platform with the t:slim X2 insulin pump and you should take actions to update your mobile app version as soon as the next version of the t:connect mobile app is available to help mitigate this risk. Tandem will notify you via email and an in-app push notification when the next version of the t:connect mobile app has been released. There is no app update action that is required at this time.
Mitigations to be taken by the Customer/User
Tandem strongly recommends that you do the following:
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||Continue using your Tandem pump and t:connect Mobile App as described in the User Guide:
a. Charge the pump for a short time every day (10 to 15 minutes) to avoid frequent full battery discharges.
b. Please monitor your pump battery level closely to ensure the pump is at or near full charge before going to sleep to help prevent pump shutdown.
c. Always carry back-up supplies.|
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If you receive a low battery alert, Tandem strongly recommends you begin charging your device as soon as possible.
What is the potential issue?
Pump Battery Depletion:
The mobile app may intermittently retrieve significantly more data than is necessary from the pump and do so repeatedly due to an app crash or being terminated and automatically relaunched by the iOS operating system. As this cycle intermittently repeats, it leads to excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner than typically expected.
Risk
As a result of a fully depleted battery, the pump may shut down earlier than typically expected. Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia, including severe hyperglycemia. The pump will provide notification prior to shut down by declaring a low power alert and alarm. In severe cases of hyperglycemia due to a prolonged period of no insulin delivery, the user may experience diabetic ketoacidosis and may require hospitalization or intervention from a medical professional.
Users may be at higher risk if the accelerated pump battery depletion occurs during the night when one is more vulnerable to missing alerts, including severe hyperglycemia due to a prolonged period of no insulin delivery.
For the t:connect mobile app version 2.7.1, there have been 107 confirmed adverse events and 2 confirmed injuries requiring hospitalization associated with accelerated pump battery depletion resulting in pump shutdown. There have been no reports of death.
