Events

Alerta De Seguridad para continuous glucose monitoring system DexCom PLATINUM G4 and DexCom G5

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Dexcom, Inc.

¿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
  • ID del evento
    I1603-87
  • Número del evento
    2013DM-0010746
  • Fecha
    2016-03-02
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=154
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer reports that he was notified of some cases in which the referenced medical devices do not receive an existing warning or sound alarm, therefore, severe hypoglycemia (low blood sugar level) or severe hyperglycemia (high blood sugar levels) may not be detected. blood), leading to the potential occurrence of adverse events on patients.

Device

continuous glucose monitoring system DexCom PLATINUM G4 and DexCom G5
  • Modelo / Serial
    MT20649-1, MT20649-2, MT22719- 1 and MT22719-2
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    It is a glucose monitoring device designed to identify trends and monitor patterns in people of two or more years with diabetes. It is designed to be used by patients in their own home and in health centers. It is an additional device that complements, but replaces, the information obtained from standard glucose monitoring devices to be used at home. It helps to detect episodes of hyperglycemia and hypoglycaemia, allowing to adjust the treatments of acute and chronic cases.
  • Manufacturer
    Dexcom, Inc

Manufacturer

Dexcom, Inc
  • Empresa matriz del fabricante (2017)
    Dexcom Inc.
  • Source
    NIDFSINVIMA