Blood glucose monitor instructions updated due to error code linked to 114 injuries

Trividia Health, a Florida-based medtech company focused on diabetes care, has updated the instructions for use for its True Metrix blood glucose monitoring systems to highlight care recommendations if a specific error occurs. Since 2014, the error has been linked to 114 serious injuries and one patient death.

This update covers the True Metrix, True Metrix Air, True Metrix Go and True Metrix Pro systems. If users of these systems ever receive an “E-5” warning, the company said they may need to “seek medical attention immediately.” 

Trividia Health explained in a new statement that the E-5 warning indicates the patient experienced a “very high blood glucose event” or there was an error with the test strip. The company thought the way their instructions were previously written may have not been clear enough, potentially leading to a delay in care. These new instructions, on the other hand, are more direct about the severity of these errors.

“You may continue to use the True Metrix products,” the company emphasized. “Products are not to be returned or replaced.”

The U.S. Food and Drug Administration shared Trividia Health’s statement on its own website to help spread the word about these new recommendations. Click here for more.