Northerner
Admin (Retired)
- Relationship to Diabetes
- Type 1
The US Food and Drug Administration (FDA) has issued a warning against the use of unauthorized diabetes devices, including insulin pumps and continuous glucose monitors (CGMs), as well as other nonapproved devices and algorithms used to create systems for automated insulin delivery.
"These unauthorized diabetes management devices have not been reviewed by the FDA to ensure they provide a reasonable assurance of safety and effectiveness for their intended use. Use of unauthorized devices could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to injury requiring medical intervention or death," according to the FDA statement.
The warning followed a case report of a patient using a system comprising an unauthorized insulin dosing device that receives electronic signals from an FDA-authorized glucose sensor and converts it to a glucose value using an unauthorized algorithm. The system gave the patient too much insulin "in response to repeated incorrect high glucose values," the FDA report says, and the patient required medical intervention.
"These devices were not designed to be used together and were combined in a way that had not been thoroughly tested for compatibility," the FDA warns.
https://www.medscape.com/viewarticle/913195
(free registration required)
"These unauthorized diabetes management devices have not been reviewed by the FDA to ensure they provide a reasonable assurance of safety and effectiveness for their intended use. Use of unauthorized devices could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to injury requiring medical intervention or death," according to the FDA statement.
The warning followed a case report of a patient using a system comprising an unauthorized insulin dosing device that receives electronic signals from an FDA-authorized glucose sensor and converts it to a glucose value using an unauthorized algorithm. The system gave the patient too much insulin "in response to repeated incorrect high glucose values," the FDA report says, and the patient required medical intervention.
"These devices were not designed to be used together and were combined in a way that had not been thoroughly tested for compatibility," the FDA warns.
https://www.medscape.com/viewarticle/913195
(free registration required)
