PlainRecalls
FDA Devices Moderate Class II Terminated

Accu-Chek Connect Diabetes Management App

Reported: February 1, 2017 Initiated: December 20, 2016 #Z-1099-2017

Product Description

Accu-Chek Connect Diabetes Management App

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.

Details

Recalling Firm
Roche Diabetes Care, Inc.
Units Affected
27243
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.
Location
Indianapolis, IN

Frequently Asked Questions

What product was recalled?
Accu-Chek Connect Diabetes Management App. Recalled by Roche Diabetes Care, Inc.. Units affected: 27243.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 1, 2017. Severity: Moderate. Recall number: Z-1099-2017.