With the US Food and Drug Administration (FDA) issuing a warning to health care providers this week that certain Medtronic insulin pumps have potential cybersecurity risks, the company said no patient issues have been reported in India so far.
While the US FDA said that Medtronic was recalling several affected MiniMed pumps and providing alternative insulin pumps to patients, insulin pumps are not being recalled in India.
Patients with diabetes using the affected models should switch their insulin pump to models that are better equipped to protect against these potential risks, the FDA said.
Medtronic India said it has started notifying customers of a potential cybersecurity risk in the MiniMed 508 and MiniMed Paradigm series of insulin pumps. These models are from 2012 and earlier.
“An unauthorised person with special technical skills and equipment could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery. At this time, we have not received any confirmed reports of unauthorized persons changing settings or controlling insulin delivery,” Medtronic India said in a statement.
“Kindly note that the insulin pumps are not being recalled and are not required to be returned. This is a safety notification only,” it added.
MiniMed 508 had been discontinued in India since 2011.
“In India, Medtronic is proactively informing the regulators and other relevant stakeholders and is in the process of working with researchers, doctors and patients to address any questions or concerns that they may have,” the US-based medical device manufacturer said. (IANS)