Events

Alerta De Seguridad para Accu-Chek Mobile System

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por 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
  • Fecha
    2014-05-23
  • Fecha de publicación del evento
    2014-05-23
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140523.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 accu-chek mobile system medical device manufacturer, roche, has issued a field safety notice concerning accu-chek mobile system. the manufacturer is introducing enhanced instructions and training for the use of the accu-chek mobile system. the new and enhanced training materials will be included in the accu-chek mobile kits and will be distributed to current accu-chek mobile users. according to the manufacturer, the strip-free accu-chek mobile blood glucose monitoring system offers a unique testing procedure, which requires particular awareness of people with diabetes regarding its proper handling. the manufacturer has identified that a small number of people with diabetes using the affected device have experienced falsely elevated blood glucose readings when using the system as a result of not following the described and labelled handling instructions. such improper handling can include, for example, unclean hands contaminated with glucose-containing substances, pressing the finger too hard and too long on the test field or smearing the blood while performing a test. the manufacturer has decided to enhance its training and handling instructions for the accu-chek mobile system to increase their visibility in the meter kit to ensure people with diabetes’ understanding of how to appropriately use the system. this will enable the users to obtain safe and reliable blood glucose (bg) readings at all times. the manufacturer advises patients that they can continue to use their accu-chek mobile device safely and reliably by carefully following the instructions included in the new training leaflet. if patients have concerns about the accuracy of a bg reading, they should refer to the possible sources of error listed in the user manual and perform a test with a control solution or they should contact their healthcare provider and follow the individual advice. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 may 2014.

Device

Accu-Chek Mobile System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Roche Accu-Chek Mobile System
  • Manufacturer
    Roche

Manufacturer

Roche