FDA has issued a safety alert warning patients and health care professionals about risks associated with using unapproved or unauthorized devices for diabetes management, including continuous glucose monitoring systems, insulin pumps and automated insulin dosing systems. The alert notes that the use of unapproved or unauthorized devices could result in inaccurate blood glucose measurements or unsafe insulin dosing, which can lead to an injury or death.
FDA says it is “aware of manufacturers illegally marketing unauthorized devices for diabetes management, which have not been reviewed by the agency for safety and effectiveness. Companies are also illegally marketing components, such as unauthorized continuous glucose monitors that some patients may integrate into unauthorized automated insulin dosing systems. Additionally, the FDA is aware of patients combining devices or components that are not intended for use with other devices.”
FDA adds that it has received a serious adverse event report in which a patient’s use of an illegally marketed continuous glucose monitoring system along with an unauthorized automated insulin dosing system resulted in insulin overdose requiring medical attention.