Events

Safety Alert for 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)

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Roche Diagnóstica Brasil Ltda.; Roche Diabetes Care GMBH.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2251
  • Date
    2017-03-29
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    Potential inaccuracy in calculating insulin boluses in accu-chek connect application versions 2.0.0, 2.0.1, 2.1.0 (ios & android).
  • Action
    Field Action Code SBN_RDC_2017_02 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company asks you to immediately stop using bolus calculus.

Device

Accu-Chek Connect Application Technical Name: Accu-Chek Connect Application Registration Number A...

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diabetes Care GMBH