09
May
2024

FDA Recall: App Crash May Lead to Pump Shut Down Suspending Insulin

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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

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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