Alerte De Sécurité sur Accu-Chek Connect Application Technical Name: Accu-Chek Connect Application Registration Number ANVISA: 10287411061 Affected Model: Versions 2.0.0, 2.0.1, 2.1.0 (iOS & Android)

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

If you use Accu-Chek Connect 2.0.0, 2.0.1, 2.1.0 (iOS & Android) versions, we request that you immediately stop using bolus calculus in those versions. We are carefully developing and testing a patched version to ensure that no such issues occur in the future. We will inform you as soon as possible as soon as this new version is available. If there is any need for further assistance on the operation of the Accu-Chek Connect system or in cases of doubt, please do not hesitate to contact our Accu-Chek Response Center at 0800 77 20 126 - Option 2. #### Update of the field action: UPDATED ON 10/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.