Trividia Health Corrects True Metrix Blood Glucose Meters Due to Injuries and Death

The FDA has issued an Early Alert concerning Trividia Health's "Urgent Medical Device Correction" for its TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO, and TRUE METRIX PRO Self-Monitoring and Professional Monitoring Blood Glucose Systems. This action is prompted by reports of injuries and death associated with the devices. The correction specifically addresses the E-5 error code, which signifies a very high blood glucose result (over 600 mg/dL) or a test strip error. Updated instructions require users experiencing this error and exhibiting symptoms of high glucose to seek immediate medical attention.

Healthcare providers, distributors, pharmacists, and consumers are instructed to notify affected patients and customers of this labeling correction. Patients are advised to follow the updated E-5 error code instructions and may continue to use the affected products, which are not to be returned or replaced. The FDA is actively reviewing the information and will provide updates as they become available. Non-compliance with device instructions, especially when experiencing symptoms, could lead to serious health consequences.