Events

Notificaciones De Seguridad De Campo acerca de Miris Human Milk Analyzer

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Miris AB.

¿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
    Field Safety Notice
  • Fecha
    2016-05-20
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    We are contacting you regarding an incident report filed to the swedish medical products agency. the incident concerned inaccurate programming ofan hma used for nutritional analysis ofhuman milk. the error was found only at analysis on the instruments calibration for unhomogenized milk, where the protein levels were overestimated. miris takes this incident very seriously. without further investigation of each instrument we are unable to rule out that no other instruments are also affected by the error, which may lead to incorrect nutrition of preterm infants. therefore, miris recommends users to stop using the hma for fortification purposes in nutritional care of pre-term infants until the instrument has been controlled and validated by miris staff.

Device

Miris Human Milk Analyzer

Manufacturer

Miris AB