Recall Z-1609-2024 ยท QFG Alternate Controller Enabled Insulin Infusion Pump
Tandem Diabetes Care, Inc.
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
| Date | May 6, 2024 (initiated Mar 5, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Software Design Change |
| Action | On 10/09/2024, Tandem send via email an "URGENT MEDICAL DEVICE CORRECTION UPDATE" informing customers of additional actions required (uninstall and reinstall mobile app version 2.8.2) to address the faster than expected battery depletion issue. Customers are instructed to: 1.Touch and hold the app icon. 2.Tap Remove App, then tap Delete App to confirm. 3.Go to Apple App Store. 4.Search t:connect mobile to locate the t:connect mobile app. 5.Tap Download, or the cloud icon with an arrow. 6.Login with your t:connect account credentials and re-pair with your Tandem t:slim X2 pump. For complete |
| Quantity | 85,863 applications |
| Distribution | US nationwide distribution including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203234 | t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) Tandem Diabetes Care, Inc., Feb 15, 2022 |