Events

Alerta De Seguridad O Notificaciones De Seguridad para NordiPen® used with 5mg and 10mg Norditropin® SimpleXx® (‘somatropin’) and NordiPenMate®

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Novo Nordisk.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2013/071
  • Número del evento
    CON314666
  • Fecha
    2013-09-05
  • Fecha de publicación del evento
    2013-09-05
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON314666?tabName=allTabs
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Notas adicionales en la data
  • Causa
    There is a risk of under-dosing as the device may not fully screw together. a change to the metal screw threads of the mechanical section may cause the user to experience increased resistance during assembly.  patients may assume the pen is correctly assembled when it is not, and therefore not receive the correct dose. the manufacturer issued field safety notice (fsn) in july and september 2013 advising users of the problem and how to assemble the devices; however, they have received insufficient reconciliation data.
  • Acción
    Ensure that all staff who are responsible for managing patients with these devices are aware of the assembly instructions in the FSNs. Identify all patients who use these devices and ensure that they receive the patient letter attached to either FSN explaining how to assemble the devices. Return the confirmation of receipt form in the FSNs to the manufacturer.

Device

NordiPen® used with 5mg and 10mg Norditropin® SimpleXx® (‘somatropin’) and NordiPenMate®
  • Modelo / Serial
  • Descripción del producto
    Growth hormone pens. NordiPen® used with 5mg and 10mg Norditropin® SimpleXx® (‘somatropin’) and NordiPenMate®. NordiPen® NordiPenMate® All devices with a lot number beginning with A or B. Lot numbers beginning with a ‘C’ are referred to in the July 2013 FSN but they were never distributed by the manufacturer. How to find the lot number The lot number is located on the mechanical section below the push button and can be exposed by turning the dose selector clockwise. The lot number in the example image begins with ‘B’.
  • Manufacturer
    Novo Nordisk

Manufacturer

Novo Nordisk