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Tandem Diabetes Care, Inc. recalls t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Recalled May 15, 2024 · FDA recall Z-1609-2024 · Tandem Diabetes Care
Hazard
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. · FDA Class I
Units
85,863 applications
Sold at
US nationwide distribution including Puerto Rico.
Description
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.
Product
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Manufacturer(s)
Tandem Diabetes Care, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →