The label update affects True Metrix, True Metrix Air, True Metrix Go and True Metrix Pro blood glucose monitoring systems. Distribution regions include the U.S., UK, Mexico, Australia and the Caribbean. It requires a modification to the systems’ owner’s booklets/system instructions for use.
Trividia Health said the update relates to the E-5 Error Code in the “Messages” section of its owner’s booklets/instructions. This change emphasizes that users must seek medical attention immediately if they receive this code and are experiencing symptoms of high glucose.
The system displays this error code for a very high blood glucose event (greater than 600 mg/dL) or in the event of a test strip error. As currently written, the instructions could potentially lead to a delay in treatment if the user fails to seek medical attention immediately. A delay in treatment can result in serious adverse health consequences or death, especially for users with very high blood glucose levels.
Since the global launch of True Metrix in August 2014, Trividia has received 114 reports of serious injuries and one report of death associated with the E-5 error code.
The correction affects all True Metrix-branded blood glucose meters distributed in the affected regions, including co-branded products sold under store or distribution partner names.
Customers may continue to use the True Metrix products and do not need to return or replace them. The company notified the FDA of its action.
