Events

Alerta De Seguridad para GlucoMen LX Sensor blood glucose test strips 50 count

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

¿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
    2013-08-15
  • Fecha de publicación del evento
    2013-08-15
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130815.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: a. menarini diagnostics glucomen lx sensor blood glucose test strips 50 count the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) issued a medical device alert and a press release concerning glucomen lx sensor blood glucose test strips 50 count (product code 38877). they are used with the glucomen lx and glucomen lx plus meter and they are manufactured by menarini in italy. the affected lot numbers are 3212214249 (expiry date 31 aug 2014) and 3212219249 (expiry date 31 aug 2014). according to the mhra, the affected lots have been contaminated during manufacture, and may give an overestimation of blood glucose levels, potentially resulting in inappropriate insulin administration. there is currently no evidence that uk patients have been affected. the mhra provides the following advice to the affected users/ healthcare personnel: identify and quarantine affected lots. identify patients using these meters and advise them that they should return and not use strips from the affected lots. ensure that users who return strips from the affected lots can continue to monitor their blood glucose. contact menarini to arrange the return of any strips from the affected lots. according to the local supplier, the affected products were not distributed in hong kong. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/newscentre/pressreleases/con305472 http://www.Mhra.Gov.Uk/publications/safetywarnings/medicaldevicealerts/con303150 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 august 2013.

Device

GlucoMen LX Sensor blood glucose test strips 50 count
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: A. Menarini Diagnostics GlucoMen LX Sensor blood glucose test strips 50 count
  • Manufacturer
    Menarini in Italy

Manufacturer

Menarini in Italy