Events

Alerta De Seguridad para accu-chek spirit combo insulin pump

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
    2014-03-12
  • Fecha de publicación del evento
    2014-03-12
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140312.html
  • 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
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: roche diagnostics accu-chek spirit combo insulin pump the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device alert concerning accu-chek spirit combo insulin pump, manufactured by roche diagnostics. the affected serial numbers are from 10171897 to 10281629 (inclusive). there is an increased risk that the vibration alarm will not work, as a result of a changed component. this fault will only be detected at pump start up, when it will display an ‘e-7’ error message and give an audible signal, but will fail to start. there is a risk of treatment delay. the manufacturer advises users that: if a delay to insulin therapy could compromise patient safety, they should consider using an alternative device. when using these pumps, they should have a syringe or insulin pen available in case the pump stops. if the pump displays an ‘e-7’ error, they should contact local supplier for a replacement. for details, please refer to mhra websitehttp://www.Mhra.Gov.Uk/publications/safetywarnings/medicaldevicealerts/con392813 if you are in possession of the product, please contact your supplier for necessary actions. posted on 12 mar 2014.

Device

accu-chek spirit combo insulin pump
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Roche Diagnostics Accu-Chek Spirit Combo insulin pump
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics