Company: Tandem Diabetes Care, Inc.
Date of Enforcement Report: May 06, 2024
Class I
PRODUCT
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology version 2.7 or later /UDI: 00850006613274
Recall Number:
Z-1609-2024
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.
RECALLING FIRM/MANUFACTURER:
Tandem Diabetes Care, Inc
VOLUME OF PRODUCT IN COMMERCE:
85,863 applications
DISTRIBUTION:
US nationwide distribution including Puerto Rico
