The FDA is warning the public against using unauthorized devices for diabetes management.
After a report of a serious adverse event from a patient using an unauthorized device, the FDA is concerned about hacked devices used alone or with other authorized devices. In the report, a patient used an unauthorized device that received an electronic signal from an FDA authorized glucose sensor and converted it to a glucose value using an unauthorized algorithm. The glucose values were sent to an unauthorized automated insulin dosing device to drive insulin dosing for the patient. As a result, the automated insulin dosing system gave too much insulin to the patient because of repeated incorrect high glucose values sent from the unauthorized device.
The FDA says that the devices are not designed to be used together and have not been thoroughly tested to be compatible. Some diabetes management devices that are for sale in the U.S. are only available in specific configurations that have been approved by the FDA. Other diabetes management devices have been authorized for use with other compatible devices, including insulin dosing systems, insulin pumps, blood glucose meters and other devices.
New risks are introduced when patients combine devices for diabetes management because the FDA has not evaluated its safety or effectiveness. Using unauthorized diabetes management devices alone or with other devices could result in inaccurate glucose level readings or unsafe insulin dosing, according to the FDA. The inaccuracies can also lead to injuries that need medical intervention.
The FDA says it is aware of manufacturers that are marketing unauthorized diabetes management devices that use an algorithm to convert raw data from an FDA authorized glucose sensor to a glucose level displayed to the patient. The algorithm has not been evaluated on the devices and the FDA warns that it may show inaccurate glucose values.