Recall Z-1609-2024— Tandem Diabetes Care, Inc.
Class I · Ongoing
Class I FDA medical device recall by Tandem Diabetes Care, Inc., initiated 2024-03-05. It names one FDA 510(k) clearance: K203234. Product: 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..
- Recalling firm
- Tandem Diabetes Care, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-03-05
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.