TRUE METRIX® PRO Product Notice

URGENT MEDICAL DEVICE CORRECTION

TRUE METRIX® PRO Professional Monitoring Blood Glucose System – E-5 Error Code Instructions

Healthcare Professional Notice

Trividia is updating the E-5 Error Code in the “Messages” section of the Owner’s Booklets to emphasize that users must seek medical attention immediately if they receive an E-5 error code and the patient is experiencing symptoms of high glucose. Trividia Health will notify users of additional mitigation strategies as needed.

The system displays an E-5 error code for a very high blood glucose event (> 600 mg/dL) or when there is a test strip error. As currently written, the instructions could potentially lead to a delay in treatment if the user does not seek medical attention immediately when they receive an E-5 error code and the patient is experiencing symptoms of high glucose. A delay in treatment may result in serious adverse health consequences or death, especially for patients with very high blood glucose levels.

UPDATED E-5 INSTRUCTIONS for TRUE METRIX PRO:

You may continue to use the TRUE METRIX® PRO Professional Blood Glucose Monitoring System. Products are not to be returned or replaced.

If you have any questions, please call Trividia Health Customer Care Department toll-free at 1-888-835-2723 Monday-Friday 8AM-8PM EST (excluding holidays) or e-mail trividia0126cc@trividiahealth.com or visit
www.trividiahealth.com/E-5productnotice