Today the FDA issued an alert to patients and healthcare professionals about unapproved and unauthorized diabetes management devices. The safety communication details a serious adverse incident in which a patient used an unauthorized device and it led to an insulin overdose that required medical intervention.
The FDA knows about manufacturers that are marketing unauthorized devices for diabetes management—devices that use an algorithm to convert raw data from an FDA authorized glucose sensor. However, this algorithm could provide inaccurate glucose values, FDA warns.
“Based on the available information, it is unclear whether the insulin overdose resulted from inaccurate glucose values reported from the unauthorized sensor, or a software malfunction in the unauthorized automated insulin dosing system that misinterpreted the electronic signal from the unauthorized continuous glucose monitoring system,” according to the FDA safety communication. The agency reminds patients that the use of unauthorized devices introduces new risks that the FDA has not evaluated for safety and effectiveness. “Patient use of unauthorized diabetes management devices, alone or along with other devices, could result in inaccurate glucose level readings or unsafe insulin dosing. These inaccuracies may lead to injuries requiring medical intervention, such as severe low blood sugar, coma, diabetic ketoacidosis (buildup of acids in blood), and death,” states FDA.