https://diabetes.acponline.org/archives/2019/06/14/7.htm

Do not use unauthorized devices for diabetes management, FDA warns

Use of such devices, either alone or with authorized devices, could result in inaccurate glucose level readings or unsafe insulin dosing, potentially leading to death or injury.


Patients should not use unapproved or unauthorized devices for diabetes management, either alone or with authorized devices, the FDA recently warned. Such devices include continuous glucose monitoring systems, insulin pumps, and automated insulin dosing systems.

Because of personal preference or for cost reasons, patients may choose to create their own systems or to purchase unauthorized or unapproved components or systems. Clinicians should be aware that use of unauthorized devices could result in inaccurate glucose level readings or unsafe insulin dosing, potentially leading to death or injury requiring medical intervention.

In one report, a patient used an unauthorized device that received the electronic signal from an FDA-authorized glucose sensor and converted it to a glucose value using an unauthorized algorithm. These glucose values were sent to an unauthorized automated insulin-dosing device, which gave too much insulin, resulting in an insulin overdose requiring medical intervention.