Company: Roche Diabetes Care, Inc.
Date of Enforcement Report 2/1/2017
Class lI:
PRODUCT
Accu-Chek Connect Diabetes Management App
Recall Number Z-1099-2017
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 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.
RECALLING FIRM/MANUFACTURER
Roche Diabetes Care, Inc., Indianapolis, IN on 12/30/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
27243
DISTRIBUTION
Nationwide
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