Events

Alerta De Seguridad para Accu-Chek Infusion System, Model: TenderLink, Brand: Roche, Record: 10287411002. Serial / Lot Numbers: 5032438/5033658/5051303/5053292/5065540/5065550.

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

¿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
    1553
  • Fecha
    2015-03-13
  • 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
    According to the record holder, if pipeline dislodges, insulin delivery is interrupted and the pump will not alarm. The consequences of this failure may culminate in hyperglycemia, which if left untreated may result in diabetic ketoacidosis (DKA). For a detailed description of the problem and handling instructions relevant to users of such infusion sets, the registrant requests the attached manufacturer's communication. #### 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
    According to the registry holder there are reports of disconnection of the tubing at the site of disconnection / connection of the infusion system.
  • Acción
    The company made a Notice to customers and guides the user, in case the tube feels loose: 1. Do not try to reconnect the tube. Immediately replace the infusion set. 2. Treat high sugar levels as directed by your healthcare professional. 3. Tell your distributor's Hotline to record the occurrence. You will be given instructions on how to return the affected infusion set. For infusion system users, following the advice below. 1. When changing your infusion set, carefully follow the "Instructions for Use" included in the package. Check the tubing at the connection / disconnection location identified in the drawings above to ensure that it is not loose. 2. Monitor your blood glucose levels with the glucose meter. Proactively control tubing connections occasionally during the day to ensure it is securely attached. It is especially important to monitor your blood sugar levels and tube connections before bedtime to confirm that insulin is being administered. 3. If your sugar levels are elevated, carefully check the tube connections and infusion site to ensure the tube is secure.

Device

Accu-Chek Infusion System, Model: TenderLink, Brand: Roche, Record: 10287411002. Serial / Lot Num...

Manufacturer

Roche Diagnostica Brasil Ltda; Roche