Recall Z-0197-2018 ยท NDC Calculator, Drug Dose
Roche Diabetes Care, Inc.
Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / GTIN number 00365702700017 The Accu-Chek Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software provides for electronic download of blood glucose meters, manual data entry, storage, display, transfer, and self-managing
| Date | Jun 8, 2017 |
| Status | Terminated |
| Reason | Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. After pairing a meter with the app for the first time, a customer may encounter the rare condition in which the countdown timer is not displayed and correction bolus advice is not available for the most recent, valid glucose reading. This same blood glucose value may become available for bolus advice calculation at a later time (countdown timer is displayed). |
| Root cause | Software design |
| Action | Roche Diabetes Care sent an Urgent Medical Device Correction letter dated June 12, 2017, to all affected customers. The potential for inaccurate bolus insulin advice can only be encountered if the blood glucose meter has displayed a single E-10 Time/Date error message and the meter had blood glucose records in My Diary and then the meter is pared for the first time with the Accu-Chek Connect App. A customer encountering this issue may find the app does not display the bolus advice option and, consequently, correction bolus advice is not available on the most recent, valid glucose reading. |
| Quantity | 1,134 bolus advisor features used |
| Distribution | Worldwide Distribution - US (Nationwide) and Canada |
| 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 |