Events

Alerta De Seguridad para Accu-Chek® Spirit and Accu-Chek® Spirit Combo, Registration: 10287410883, Hazard Class III, Serial Numbers: SEE ANNEX.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1609
  • Fecha
    2015-05-25
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la 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.
  • Causa
    Increased mechanical error of the infusion pumps in the cartridge exchange process.
  • Acción
    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