t:connect Mobile Application, Mobile Bolus Enabled (iOS) 1007111Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 90850018992452), received between Sep 9, 2022 and Mar 6, 2024 — classified as 2 injuries, 1 malfunction.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2024

  TANDEM DIABETES RELEASED NEW T:CONNECT IOS SOFTWARE THAT INCREASED INSULIN PUMP POWER USE. TANDEM DIABETES HAS NOT NOTIFIED USERS OF DEFECTIVE SOFTWARE. THIS REPORT IS TO URGE FDA TO INVESTIGATE COMMUNICATION PRACTICES OF TANDEM DIABETES AND REQUIRE MUCH MORE TRANSPARENCY. REFERENCE REPORT: MW5152428.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18856049 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CONTACT ACCIDENTALLY REQUESTED AND DELIVERED A 3 UNIT BOLUS VIA THE T:CONNECT MOBILE APPLICATION INSTEAD OF A BOLUS FOR 3 GRAMS OF CARBOHYDRATES. SUBSEQUENTLY, CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL DECREASED TO 40 MG/DL. REPORTEDLY, THE CUSTOMER CONSUMED CARBOHYDRATES TO ADDRESS BG LEVEL. RECOMMENDATION WAS MADE TO CONSULT WITH HEALTHCARE PROVIDER REGARDING DIABETES MANAGEMENT.

  Patient problems: Hypoglycemia

  MAUDE report 17190487 ↗
• InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM DUE TO LOW BLOOD GLUCOSE (BG) LEVEL OF 31MG/DL. THE CUSTOMER CONSUMED CARBOHYDRATES AND WAS TREATED WITH INTRAVENOUS SALINE TO ADDRESS BG LEVEL. THE CUSTOMER WAS DISCHARGED ON (B)(6) 2022 WITH NO PERMANENT INJURY. TANDEM TECHNICAL SUPPORT (CTS) REVIEWED PUMP DATA LOGS AND DETERMINED THAT THE CUSTOMER REQUESTED AND DELIVERED A 15 UNIT BOLUS VIA THE TANDEM MOBILE APPLICATION. REPORTEDLY, THE CUSTOMER HAD INTENDED TO DELIVER A 1.5 UNIT BOLUS. CTS EDUCATED THE CUSTOMER ON PROPER BOLUS DELIVERY PROCEDURE.

  Patient problems: Hypoglycemia

  MAUDE report 15396771 ↗