Trividia Health Issues Label Correction for Glucose Monitoring Systems After Reports of 114 Serious Injuries, 1 Death

Since the TRUE METRIX line was introduced globally in 2014, 114 serious injuries and one death have been reported in connection with the E-5 code.

Rudy Blalock

Published: 2/9/2026, 11:41:58 PM EST

Trividia Health Issues Label Correction for Glucose Monitoring Systems After Reports of 114 Serious Injuries, 1 Death — A form of blood glucose testing record in a stock photo. (Shutterstock)

A Florida-based company issued a labeling correction Friday for its glucose monitoring systems that have caused more than 100 serious injuries and one death due to a device error code warning.

Trividia Health, Inc., said the issue affects all of its TRUE METRIX® Blood Glucose Monitoring Systems used in the United States and several other countries.

The U.S. Food and Drug Administration (FDA) announced Friday that the correction impacts all TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO, and TRUE METRIX PRO meters distributed in the United States, the United Kingdom, Mexico, Australia, and the Caribbean.

The issue centers on the E-5 error code that appears on meters during either an extremely high blood glucose reading—above 600 mg/dL—or a test strip malfunction. The company said its existing instruction manuals and owner’s booklets “fails to emphasize that users must seek medical attention immediately if they receive an E-5 error code and are experiencing symptoms of high glucose.”

Trividia Health said it is updating that guidance to make the warning clearer. The company acknowledged that, as currently written, the lack of emphasis could contribute to dangerous treatment delays. “A delay in treatment may result in serious adverse health consequences or death, especially for users with very high blood glucose levels,” the company said.

Since the TRUE METRIX line was introduced globally in 2014, 114 serious injuries and one death have been reported in connection with the E-5 code.

While the systems are not being recalled or replaced, new labeling materials will be distributed to pharmacies, mail-order businesses, and distributors. Trividia said customers should continue using their meters and review the updated instructions available at www.trividiahealth.com/E-5productnotice.

The company has notified the FDA about the labeling update and urged users who experience adverse effects or device issues to report them through the FDA’s MedWatch Adverse Event Reporting program, either online or by mail or fax.

The notice comes just days after the FDA classified another diabetes monitoring device recall—the November 2025 recall of Abbott Diabetes Care’s glucose sensors—as “the most serious type.” According to a Feb. 2 FDA statement, Abbott, a division of Abbott Laboratories, had reported 860 cases of serious injuries and seven deaths globally linked to faulty sensors that could relay dangerously low glucose readings.

“The FDA has identified this recall as the most serious type,” the agency said, warning that the devices “may cause serious injury or death if someone were to continue using it.”

Abbott said customers can verify whether their FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors are affected by visiting www.freestylecheck.com and requesting replacements if necessary.

According to the American Diabetes Association, more than 38 million Americans live with diabetes, a condition that cost the United States an estimated $412.9 billion in 2022.

For questions about the updated instructions, consumers can contact Trividia Health’s Customer Care Department at 1-888-835-2723 or by email at [email protected].

Correction: This article's previous headline has been corrected. NTD regrets the error.