“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.
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.