Tandem Diabetes Care, Inc. is recalling version 2.7 (released February 12, 2024 on the Apple iOS platform) of the t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology by correction. The reason for the recall is due to an issue with the software that may cause the mobile app to 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 or even diabetic ketoacidosis, which can be a life-threatening condition due to high blood sugars and lack of insulin.
There have been 224 reported injuries as of April 15, 2024 and no reports of death.
The recalled t:connect mobile app is an Apple iOS-based software and is for Version 2.7 of the mobile app. The t:connect mobile app works with the t:slim X2 insulin pump with Control-IQ technology.
The t:connect mobile app can also be used as a method of viewing pump information and limited control of the pump through compatible smartphone models, operating systems and pump software versions.
The t:slim X2 insulin pump is intended to deliver insulin under the skin (subcutaneous delivery), at set and variable rates, for the management of diabetes in persons requiring insulin. It can connect securely with other devices like insulin dosing software. The Control-IQ technology works with compatible continuous glucose monitors and pumps to adjust insulin delivery based on glucose readings, both current and predicted, and can give extra insulin as needed.
On March 26, 2024, Tandem Diabetes Care, Inc. sent all affected customers an Urgent Medical Device Correction. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. This recall is a correction, not a product removal.
Medical Device Recalls
FDA uses the term “recall” when a manufacturer takes a correction or removal action to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.
Class I: A situation where there is a reasonable chance that a product will cause serious health problems or death.
Class II: A situation where a product may cause a temporary or reversible health problem or where there is a slight chance that it will cause serious health problems or death.
Class III: A situation where a product is not likely to cause any health problem or injury.
Once classified, the FDA monitors the recall to ensure that the recall strategy has been effective. Only after the FDA is assured that a product no longer violates the law and no longer presents a health hazard, does the FDA terminate the recall.
If you or a loved one suffered serious harm (or worse) as a result of a recalled medical device in the United States, you should promptly find a defective medical device lawyer in your state who may investigate your recalled medical device claim for you and represent you or your loved one in a recalled medical device case, if appropriate.
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