Trividia Health, Inc. announced on February 6, 2026, that it is initiating a labeling correction for all TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO, and TRUE METRIX PRO blood glucose monitoring systems distributed in the United States, United Kingdom, Mexico, Australia, and the Caribbean.
The correction updates the Owner’s Booklets and System Instructions for Use to emphasize that users must seek immediate medical attention if they receive an E-5 error code and are experiencing symptoms of high blood glucose. The E-5 error code appears when the system detects a very high blood glucose level above 600 mg/dL or when a test strip error occurs.
According to the company, the existing instructions did not sufficiently stress the need for immediate medical care when symptoms of high glucose are present, which could potentially lead to delayed treatment. Delayed treatment may result in serious adverse health consequences or death, particularly for users with very high blood glucose levels.
Since the global launch of TRUE METRIX products in August 2014, Trividia Health reported 114 serious injuries and one death associated with the E-5 error code.
Under the updated instructions, users are advised to retest with a new test strip if an E-5 error code appears. If the error persists and the user has symptoms such as fatigue, excessive urination, thirst, or blurry vision, they are instructed to seek medical attention immediately. If no symptoms are present and the error continues after retesting, users are directed to contact Trividia Health for assistance.
The labeling correction applies to all TRUE METRIX-branded meters, including cobranded products sold under partner or store names. The company is distributing a product notice to pharmacies, mail-order companies, and distributors, with instructions to post the notice and share it with device users when possible.
Trividia Health stated that the products may continue to be used and do not need to be returned or replaced. The correction does not require removal of the devices from use or sale. Updates apply to printed materials included with the meters and to online labeling and help guides.
The company has notified the U.S. Food and Drug Administration of the action. Users and healthcare professionals may report adverse events or product issues through the FDA’s MedWatch Adverse Event Reporting program.
Trividia Health is based in Fort Lauderdale, Florida, and develops, manufactures, and markets blood glucose monitoring products for people with diabetes.
