Events

Safety Alert for MINIMED Insulin pump

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Medtronic B.V. || Medtronic Minimed.

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
    I1705-190
  • Event Number
    2015EBC-0013970
  • Date
    2017-05-24
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=86
  • 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

Device

MINIMED Insulin pump
  • Model / Serial
  • Product Description
    The 640G DE MINIMED system is indicated for the continuous administration of insulin, at fixed and variable rates, for the treatment of diabetes mellitus in people who need insulin. In addition, the system is indicated to perform a continuous or periodic control of glucose levels in the fluid under the skin, as well as to detect possible episodes of high and low glucose. When a sensor and a transmitter are used, the pump displays continuous glucose values from the sensor and stores these data so that they can be analyzed in order to track the patterns and improve the treatment of diabetes. These data can be downloaded to a PC to analyze the historical glucose values. The continuous glucose sensor values provided by the 640G DE MINIMED system should not be used directly to make adjustments in therapy, but rather provide an indication that confirmation may be necessary. by digital puncture. All therapy settings should be based on the measurements obtained with a blood glucose monitor and not with the value shown by the pump.
  • Manufacturer
    Medtronic B.V. || Medtronic Minimed

Manufacturer

Medtronic B.V. || Medtronic Minimed
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “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
    NIDFSINVIMA