Alerta De Seguridad para accu-chek flexlink plus infusion sets

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Roche Diagnostics.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Press release
  • Causa
    Safety alert on accu-chek flexlink plus infusion sets the department of health (dh) today (march 2) warned the public not to use accu-chek flexlink plus infusion sets, manufactured by roche diagnostics (roche), because of the potential for under delivery of insulin due to a kinked cannula when inserting the infusion set. the dh, through its routine surveillance of medical devices, noticed that roche has announced a recall of the above product. roche's investigation into complaints regarding kinked cannulas revealed that in some cases the distance between the needle cut and the end of the soft cannula is too small and may contribute to an impaired cannula. the malfunction of infusion sets may result in under delivery of insulin leading to elevation of blood glucose levels, or hyperglycemia. symptoms of hyperglycemia include nausea/vomiting, blurred vision, excessive thirst or hunger, frequent urination, fatigue and headache. a dh spokesman remarked that hyperglycemia is a significant health risk, as untreated hyperglycemia may lead to death in serious cases. although preliminary investigation has revealed that there is neither record of marketing of the product nor report of such adverse events in hong kong, the potentially serious consequences and the fact that there may be occasional patients here who have somehow obtained the devices overseas justify a public alert. roche diagnostics (hong kong) ltd has set up a hotline, 2485 7512, to answer public enquiries from 9am to 12 noon, and from 2pm to 5pm between monday and friday. meanwhile, dh has informed all public and private hospitals and medical professional associations about the matter and advised them to remain vigilant. the spokesman said: "dh will closely monitor developments. members of the public should consult their healthcare professionals for advice if in doubt or feel unwell." ends/wednesday, march 2, 2011 issued at hkt 16:35.