Device product
Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017
Z-0625-2018
Product summary
- Event
- Event 79001
- Status
- Terminated
- Classification
- Class II
- Quantity
- 67,040 unique users of version 2.1.0
- Official record key
device-enforcement:Z-0625-2018
Official wording
Reason: Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Due to a software bug, when the OS region of the phone setting is changed, the unit of measure within the app may unexpectedly change. This creates a risk the app might not transfer the blood glucose result or the user might not correctly input numerical values for carbohydrate used for bolus advice.
Code information: Software Versions: 1.2.0, 1.2.2, 1.2.3, 2.0.0, 2.0.1, and 2.1.0
Distribution pattern: US Nationwide
Derived failure modes
-
Device software or design
software bug