Events

Alerta De Seguridad para GLUCOFACTS DELUXE software version 3.01

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Bayer Healthcare.

¿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
    2012-09-11
  • Fecha de publicación del evento
    2012-09-11
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120911.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: bayer glucofacts deluxe software version 3.01 the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning glucofacts deluxe software version 3.01 manufactured by bayer healthcare. according to bayer, with english as the language setting within glucofacts deluxe software, the default time format used for display is a 12 hour time format (am/pm). the issues with glucofacts deluxe software version 3.01 include the following: "am" and "pm" designations do not appear in association with the time stamp in the logbook view, pm times are listed with a "0" in front of them for times earlier than 10:00 pm. for example, 5:00 pm is reported as 05:00. bayer explained that the results viewed on the meter are not affected by the time stamp issue. this issue only occurs when results are viewed on a computer. to interpret the results and the associated time stamps appropriately in the logbook view of glucofacts deluxe, bayer advised the users to review the column headings for the appropriate time of day. in addition, bayer will provide a software update which will be available online to correct the issue. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/ safetywarningsalertsandrecalls/fieldsafetynotices/con184398 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 11 september 2012.

Device

GLUCOFACTS DELUXE software version 3.01
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Bayer GLUCOFACTS DELUXE software version 3.01
  • Manufacturer
    Bayer Healthcare

Manufacturer

Bayer Healthcare
  • Empresa matriz del fabricante (2017)
    Bayer AG
  • Source
    DH