The United States Food and Drug Administration (FDA) has warned on the risks associated with the use of devices for diabetes management unauthorised for sale in the US, whether used alone or along with other devices.

These unauthorised 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 unauthorised devices could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to injury requiring medical intervention, or death.

The FDA received a report of a serious adverse event in which a patient used an unauthorised device that receives the electronic signal from an FDA authorised glucose sensor and converts it to a glucose value using an unauthorised algorithm. Glucose values from this unauthorised continuous glucose monitoring system were sent to an unauthorised automated insulin dosing device. The automated system gave too much insulin in response to repeated incorrect high glucose values sent from the continuous glucose monitoring system. This resulted in an insulin overdose requiring 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 has authorised diabetes devices that are designed to work safely alone, and with other devices, such as integrated continuous glucose monitoring systems and “automated controller enabled” insulin pumps that comprise diabetes therapy systems. This allows patients to safely tailor their diabetes management.

Source: USFDA

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