UNITED STATES – As reported online by www.fda.gov, the Food and Drug Administration (FDA) issued a safety notification warning of potential cybersecurity risks of using Medtronic MiniMed Insulin Pumps.
Medtronic, a medical device manufacturer, has recalled certain models of its MiniMed 508 and MiniMed Paradigm insulin pumps, citing potential cybersecurity risks. Specifically, the FDA safety notification states that an “unauthorized person (someone other than a patient, patient caregiver, or health care provider) could potentially connect wirelessly to a nearby MiniMed insulin pump with cybersecurity vulnerabilities.”
Affected models of the MiniMed 508 and MiniMed Paradigm insulin pumps were sold both in and outside the United States. Individuals who used one of the affected insulin pumps outside of the United States will receive a notification from Medtronic directly with instructions for what steps to take in accordance with their countries’ laws.
While there are no reports of harm to patients, the cybersecurity vulnerabilities pose a risk of harm to patients as an unauthorized person could alter the insulin pump’s settings to release more insulin than intended to the patient or stop the flow of insulin entirely. A patient who receives an excessive amount of insulin may become hypoglycemic (low blood sugar), and a patient whose insulin supply stops may develop high blood sugar and diabetic ketoacidosis.
Medtronic is unable to update the MiniMed insulin pump software system to eliminate cybersecurity risks. As such, both Medtronic and the FDA are recommending patients replace their MiniMed insulin pumps with another pump that may be better able to protect against cybersecurity risks. Patients should speak with their doctors to determine which insulin pump model is the best option for a replacement.
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