Alerta De Seguridad para MiniMed Silhouette and MiniMed Sure-T infusion sets

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

¿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
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • 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: medtronic minimed silhouette and minimed sure-t infusion sets medical device manufacturer, medtronic limited, has issued a medical device safety alert concerning its minimed silhouette and minimed sure-t infusion sets. as part of its global quality monitoring process, the manufacturer has identified an increase in reports of the tubing becoming detached at the connect/disconnect location on the minimed silhouette and minimed sure-t infusion sets. if tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify the patient. the interruption of insulin delivery can cause hyperglycemia, which if left untreated, can result in diabetic ketoacidosis (dka). dka is a serious condition that can cause a severe impact to health, including death. symptoms of dka may include nausea, vomiting, shortness of breath and excess thirst/urination. patients should seek medical attention immediately if they experience any of these symptoms. according to the manufacturer, patients can continue to use their infusion sets by following the advice below: when changing the infusion set, patients should closely follow the instructions for use included in the product box. they should check the tubing at the site connector location identified in the drawings above to make sure it is not loose. as always, it is essential to monitor blood sugar levels frequently using a blood glucose meter. they should proactively check the tubing connections occasionally throughout the day to ensure tubing is secure. it is especially important to check blood sugar and tubing connections at bedtime to confirm insulin delivery is occurring.. if the patients experience a high blood sugar, they should check the tubing connections and infusion site closely to ensure tubing is secure. if the patients discover the tubing is detached, they should follow the instructions below: do not attempt to reattach the tubing. they should replace the infusion set immediately. treat any high blood sugar based on the guidelines provided. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 november 2014.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medtronic MiniMed Silhouette and MiniMed Sure-T infusion sets
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source