Recall Z-1099-2017— Roche Diabetes Care, Inc.
Class II · Terminated
Class II FDA medical device recall by Roche Diabetes Care, Inc., initiated 2016-12-20, terminated 2017-09-05. It names one FDA 510(k) clearance: K150910. Product: Accu-Chek Connect Diabetes Management App. 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
- Roche Diabetes Care, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-12-20
- Terminated
- 2017-09-05
- Firm location
- Indianapolis, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.