Accu-Chek Connect Diabetes Management App

FDA device recall Z-1099-2017 · posted 2017-01-26 · Terminated

Recall details

Recalling firm

Roche Diabetes Care, Inc.

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.

Action taken

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 sent on January 10, 2017, to US HCPs who have received prescription pads that would allow them to prescribe the bolus advice activation. If you have additional concerns, please contact the Accu-Chek Customer Service Center at 1- 800-858-8072. All other versions of the app as well as other Accu-Chek products using the bolus advice feature are not affected by this issue.

Root cause

Software design

Status

Terminated

Product code

NDC

Quantity 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 di

Date initiated

2016-12-20

Date posted

2017-01-26

Date terminated

2017-09-05

Location

Indianapolis, IN

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