Accu-Chek Connect Diabetes Management App
Check against the official notice below — it lists the full affected range.
Roche Diabetes Care is recalling the Accu-Chek Connect app for iOS and Android due to software problems that could provide incorrect insulin dosing recommendations. On both platforms, the app may disregard historical bolus data and give inaccurate bolus insulin recommendations. On iOS specifically, when using multiple meters with the app, the bolus advisor may fail to provide a correction bolus recommendation within the proper timeframe (10-15 minutes) after a blood glucose measurement. Both versions may also display an incorrect amount of active insulin during bolus calculation, which users should not rely on for manual insulin calculations. Depending on an individual's metabolic situation, these issues could potentially lead to serious health consequences such as hypoglycemia.
The affected app versions have been distributed worldwide to consumers directly through the Apple App Store (iOS) and Google Play App Store (Android), with approximately 27,243 units distributed. The source document does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
iOS and Android: Under certain conditions the affected app versions may disregard historical bolus data potentially leading to an incorrect bolus insulin recommendation being provided to the user. iOS only: Pairing and using multiple meters with the Accu-Chek Connect app can under rare circumstances cause the bolus advisor to fail to offer a correction bolus recommendation within the eligible time window following a blood glucose measurement (10 15 minutes). Depending on the individual metabolic situation potentially incorrect bolus advice could lead to serious health consequences such as hypoglycemia. Both software issues may also cause the amount of active insulin displayed during the bolus calculation process to be incorrect and should not be used to manually calculate a bolus.
Reason for recall: iOS and Android: Under certain conditions the affected app versions may disregard historical bolus data potentially leading to an incorrect bolus insulin recommendation being provided to the user. iOS only: Pairing and using multiple meters with the Accu-Chek Connect app can under rare circumstances cause the bolus advisor to fail to offer a correction bolus recommendation within the eligible time window following a blood glucose measurement (10 15 minutes). Depending on the individual metabolic situation potentially incorrect bolus advice could lead to serious health consequences such as hypoglycemia. Both software issues may also cause the amount of active insulin displayed during the bolus calculation process to be incorrect and should not be used to manually calculate a bolus. Distribution: Worldwide Distribution - Nationwide Distribution The Accu-Chek Connect App for iOS is distributed directly to end users via the Apple App Store. The Accu-Chek Connect App for Android is distributed directly to end users via the Google Play App Store. Quantity: 27243 Lot/code info: Catalog number 07562462001 / GTIN number 00365702700000 Catalog number 07250452001 / GTIN number 00365702700017
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.