Events

Safety Alert for Accu-Chek® Spirit and Accu-Chek® Spirit Combo, Registration: 10287410883, Hazard Class III, Serial Numbers: SEE ANNEX.

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 Diagnostics 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
    1609
  • Date
    2015-05-25
  • 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
    Explanatory letter and accompanying instruction guide. ##### 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
    Increased mechanical error of the infusion pumps in the cartridge exchange process.
  • Action
    The company has improved its handling instructions for the Accu-Chek® Spirit Combo system. With these new handling instructions we hope to ensure that all users of the Accu-Chek® Spirit Combo insulin pump can swap the insulin cartridge easily without the risk of insulin running into the cartridge compartment. If any customer, while handling the equipment and error message E6 and E10 appear on the screen, contact the company's Relationship Center.

Device

Accu-Chek® Spirit and Accu-Chek® Spirit Combo, Registration: 10287410883, Hazard Class III, Seria...

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH