The notice — dated this month — covers the company’s MiniMed 600 series insulin pumps (MiniMed 630G and 670G). Affected devices also include the Guardian Link 3 transmitter, Contour Next Link 2.4 blood glucose monitor and the CareLink USB.
Medtronic recently identified a potential issue through internal testing with the devices. Under specific circumstances, unauthorized access could compromise communication between the pump system’s components.
The company said it has no evidence to date that any such issue has occurred. Likewise, the FDA said it is not aware of any reports related to this cybersecurity vulnerability.
However, should unauthorized access happen, it could be used to deliver too much or too little insulin. The unauthorized person could deliver an unintended bolus or slow/stop insulin delivery.
In these cases, too much insulin may result in hypoglycemia (low blood sugar), potentially causing seizure, coma or death. Too little insulin could result in hyperglycemia (high blood sugar), which can lead to diabetic ketoacidosis (DKA).
The FDA said it is working with Medtronic to identify, communicate, and prevent adverse events related to the cybersecurity vulnerability.
Earlier this year, Medtronic CEO Geoff Martha cited uncertainty over approval timing for Medtronic’s next-generation platforms. That includes the MiniMed 780G insulin pump and Guardian 4 CGM sensor.
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