Alerta De Seguridad para Viterion V100 and V500 Telehealth Monitors

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

¿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
    2012-12-11
  • Fecha de publicación del evento
    2012-12-11
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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: viterion v100 and v500 telehealth monitors the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning viterion v100 and v500 telehealth monitors manufactured by viterion telehealthcare. according to viterion, the affected models v100 and v500 do not accept out-of-measuring-range results, i.E. results marked “hi” or “lo” from certain blood glucose meters. the affected meters are bayer’s contour and roche’s accu-chek advantage 03 and 04 meters. this out-of-measuring-range data is not being sent from the patients’ telehealth monitors to the clinician application software (eunet), and hence the healthcare professionals are not able to review the out-of-measuring-range patient blood glucose data. moreover, for those patients with diabetes who are instructed by their healthcare professional to enter blood sugar results manually on these monitors, only results between 1.1 and 33.3 mmol/l may be entered. results outside of the meter’s measurable range cannot be manually entered on these viterion monitors. viterion advises the affected patients, who see hi or lo displayed on the blood glucose meter, to contact their healthcare professional immediately. besides, healthcare professionals should watch out for any ‘skipped’ or ‘timeout’ values seen in patient reports. according to the local supplier, the affected products have not been distributed in hong kong. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con213146 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 december 2012.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Viterion V100 and V500 Telehealth Monitors
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DH