Events

Safety Alert for continuous glucose monitoring system DexCom PLATINUM G4 and DexCom G5

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Dexcom, Inc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    I1603-87
  • Event Number
    2013DM-0010746
  • Date
    2016-03-02
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=154
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    MT20649-1, MT20649-2, MT22719- 1 and MT22719-2
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Product Description
    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
  • Manufacturer Parent Company (2017)
    Dexcom Inc.
  • Source
    NIDFSINVIMA