MiniMedâ„¢ 780G system

Unsafe

MEDTRONIC, INC.

Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm

Strong magnetic fields can cause the system to malfunction, and result in serious injury. Magnetic fields, and direct contact with magnets, may affect the accurate functioning of the system which may lead to health risks such as hypoglycemia or hyperglycemia. Remove the pump, sensor, transmitter, and meter before entering a room with x-ray, MRI, diathermy, or CT scan equipment. The magnetic fields and radiation in the immediate vicinity of this equipment can make the devices nonfunctional or damage the part of the pump that regulates insulin delivery, possibly resulting in over-delivery and severe hypoglycemia.

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