FDA Enforcement
Class I
Ongoing
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Recall: Z-1609-2024
·
Reported May 15, 2024
Enforcement
- Recall Number
- Z-1609-2024
- Event ID
- 94312
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Tandem Diabetes Care, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 15, 2024
- Initiation Date
- March 5, 2024
- Classification Date
- May 6, 2024
- Address
- 11075 Roselle St, N/A, San Diego, CA, 92121-1204, United States
Description
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
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 Info
version 2.7 or later /UDI: 00850006613274
Distribution
US nationwide distribution including Puerto Rico.
Quantity
85,863 applications