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 for compatibility.
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