Device product
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Z-1609-2024
Product summary
- Event
- Event 94312
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 85,863 applications
- Official record key
device-enforcement:Z-1609-2024
Official wording
Reason: During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner 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.
Code information: version 2.7 or later /UDI: 00850006613274
Distribution pattern: US nationwide distribution including Puerto Rico.
Derived failure modes
-
Unknown
During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner 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.