Events

Alerta De Seguridad para accu-chek spirit combo insulin pumps

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
    2014-10-03
  • Fecha de publicación del evento
    2014-10-03
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141003a.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 pumps the australia therapeutic goods administration (tga) posted a medical device safety alert concerning accu-chek spirit combo insulin pumps manufactured by roche diagnostics. the manufacturer has become aware that in a limited number of cases, patients using the accu-chek spirit combo insulin pump may experience a loss of the date and time settings. investigation of the situation revealed that this issue may occur if the pump capacitor fails to function properly due to a leakage. the capacitor provides the necessary voltage to save time and date settings during power interruption, typically during a battery change. the manufacturer is advising end users and healthcare professionals of the potential issue. end users are advised to ensure that the time and date are set correctly after a battery change. users who experience any failures are requested contact the manufacturer to arrange for a replacement pump. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to the following link:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-01063-1 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 03 october 2014.

Device

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

Manufacturer

Roche Diagnostics