Events

Alerta De Seguridad para Accu-Chek Insight insulin pump cartridge (self-filled)

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
    2015-03-03
  • Fecha de publicación del evento
    2015-03-03
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150303.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: accu-chek insight insulin pump cartridge (self-filled) the medicines and healthcare products regulatory agency (mhra) posted a medical device safety alert concerning accu-chek insight insulin pump cartridge (self-filled) manufactured by roche diagnostics. [lot numbers: 1083036, 1083193, 1083533, 1083534, 1083535, 1083536, 1083537, 1089205, 1089206, 1090593, 1090763, 1091203, 1091204, d04032014, d14112013] the manufacturer has become aware of a potential insulin leakage occurring with some manufacturing lots of the accu-chek insight insulin pump cartridge (self-filled) used with the accu-chek insight insulin pump system. the potential risk is smaller than expected doses of insulin may be delivered if insulin leakage occurs. patient may experience too high blood glucose levels, which if left untreated, can result in a diabetic ketoacidosis. death could result. the manufacturer is advising end users not to use and discard any cartridges of the above listed lots. according to the local supplier, the affected products are not distributed in hong kong. for details, please refer to the following link: http://mhra.Filecamp.Com/public/file/28bg-c089h6uh if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 03 march 2015.

Device

Accu-Chek Insight insulin pump cartridge (self-filled)
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Accu-Chek Insight insulin pump cartridge (self-filled)
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics