Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1099-2017 — Accu-Chek Connect Diabetes Management App

U.S. FDA — Device Enforcement · United States · 2016-12-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1099-2017
Date of alert
2016-12-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Roche Diabetes Care, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07562462001
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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