Recall Z-1099-2017 ยท NDC Calculator, Drug Dose
Roche Diabetes Care, Inc.
Accu-Chek Connect Diabetes Management App
| Date | Jan 26, 2017 (initiated Dec 20, 2016) |
| Status | Terminated |
| Reason | 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 hyp |
| Root cause | Software design |
| Action | Customers were notified via Google Play Store or the Apple App Store that an update to the Accu-Chek Connect App was available on December 20, 2016.. The description of the new version available in the app stores indicated that the new version resolved issues with the Bolus Advisor. It also includes direction to the Accu-Chek website. On December 21, 2016, information regarding the issues corrected with the new version was placed on the website. The information on the website was replaced on January 10, 2017, with the patient version of the Urgent Medical Device Correction (UMDC) which was |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150910 | ACCU-CHEK Connect Diabetes Management App Roche Diabetes Care, Inc., Jun 3, 2015 |