Updated Labeling Guidance and Safety Measures Address E-5 Error Code While Company Develops Long-Term Software Solution
Trividia Health, Inc., a globally recognized leader in diabetes care and blood glucose monitoring solutions, has issued an updated communication regarding its previously announced medical device labeling correction for its TRUE METRIX® family of blood glucose monitoring systems. This update builds upon the company’s initial notification released on February 6, 2026, and provides additional clarity, guidance, and reassurance for patients, healthcare professionals, and distribution partners.
The correction applies to all products within the TRUE METRIX portfolio, including TRUE METRIX®, TRUE METRIX® AIR, TRUE METRIX® GO, and TRUE METRIX® PRO blood glucose monitoring systems. Collectively referred to as the “Products,” these devices are widely used across the United States for routine blood glucose testing by individuals managing diabetes.
Background and Ongoing Actions
Following the initial February announcement, Trividia Health has been actively working to implement corrective measures focused on improving device labeling and enhancing user awareness. The company has updated instructions associated with the E-5 Error Code, a specific alert that may appear during glucose testing. These updates are designed to ensure users correctly interpret and respond to the error message, thereby minimizing potential health risks.
As part of this effort, revised messaging has already been incorporated into packaging materials. Patients and healthcare providers may now notice updated E-5 Error Code instructions included in new TRUE METRIX meter boxes as well as in test strip packaging. These updates aim to provide immediate, accessible guidance at the point of use.
Trividia Health is continuing to collaborate closely with the U.S. Food and Drug Administration (FDA) to refine and implement a long-term corrective strategy. This partnership ensures that all actions meet regulatory standards while prioritizing patient safety and device reliability.
Important Safety Information for Users
The company emphasizes that accurate and timely blood glucose readings are critical for effective diabetes management. Any delay in recognizing dangerously low (hypoglycemia) or high (hyperglycemia) blood sugar levels may increase the risk of serious health complications, including delayed treatment.
Patients currently using TRUE METRIX, TRUE METRIX AIR, or TRUE METRIX GO meters are advised to carefully review the updated instructions regarding the E-5 Error Code. If an alternative method of blood glucose testing is available, users may consider transitioning temporarily while updates are being finalized. However, those who continue using their existing devices should strictly follow the revised guidance provided in the updated labeling.
Certain patient groups may face higher risks, particularly those who:
- Rely on intensive insulin therapy
- Use medications such as sulfonylureas
- Experience frequent episodes of hypoglycemia or hyperglycemia
For these individuals, exploring alternative glucose monitoring options—after consulting with a healthcare provider—is strongly recommended until updated systems become available.
Trividia Health encourages all users to speak with their healthcare professionals or pharmacists to determine whether continued use of current TRUE METRIX devices is appropriate based on individual medical needs and risk factors.
Development of Updated Devices and Upgrade Program
As part of its long-term solution, Trividia Health has determined that software enhancements to the TRUE METRIX meters will provide the most effective resolution. The company is actively developing these updates in coordination with regulatory authorities.
Once finalized and approved, the updated meters will be introduced across the entire TRUE METRIX product line. Following this rollout, Trividia Health plans to launch a comprehensive upgrade program. This initiative will allow users to replace currently distributed devices with the newly updated versions.
The company has committed to notifying customers and stakeholders as soon as the upgrade program becomes available, ensuring a smooth and transparent transition process.
Scope of the Notice
This updated communication applies to all TRUE METRIX-branded blood glucose monitoring systems distributed within the United States. It also includes co-branded versions of these products that are sold under various retail or distribution partner names.
To assist users, Trividia Health has made additional resources available online, including:
- A complete list of affected products and co-brand partners
- Updated product notices and user instructions
- Revised owner’s manuals
- A serial number lookup tool to identify impacted devices
These resources are accessible through the company’s official website.
Communication with Distribution Partners
Trividia Health is actively distributing updated product notices to pharmacies, distributors, and mail-order providers. These partners are being instructed to:
- Share the updated information with end users
- Display notices in areas where the products are stored or sold
- Ensure that patients are aware of the updated instructions and safety guidance
This coordinated approach is intended to maximize awareness and minimize any potential risks associated with device usage.
Reporting Issues and Adverse Events
The company has formally notified the FDA of this correction and continues to work under regulatory oversight. Patients and healthcare providers are encouraged to report any adverse events or product quality concerns through the FDA’s MedWatch Adverse Event Reporting Program.
Reports can be submitted through multiple channels, including:
- Online submission via the MedWatch website
- Mail using downloadable reporting forms
- Fax submission using official FDA documentation
These reporting mechanisms play a vital role in ongoing safety monitoring and product improvement.
Commitment to Patient Safety
Trividia Health reiterates that patient safety remains its highest priority. The company acknowledges the inconvenience this situation may cause and is committed to resolving the issue as quickly and effectively as possible.
Through proactive communication, product updates, and collaboration with regulatory authorities, Trividia Health aims to ensure that individuals living with diabetes can continue to rely on accurate, dependable blood glucose monitoring solutions.
For further assistance, users can contact Trividia Health’s Customer Support team or visit the company’s official website for the latest updates and guidance.
About Trividia Health
Trividia Health, Inc., is a global health and wellness company based in Fort Lauderdale, Florida and a leading developer, manufacturer and marketer of advanced performance products for people with diabetes. With products sold under TRUE and store brand labels, the company is the exclusive partner and supplier of affordable, high-quality blood glucose monitoring and health and wellness solutions for the world’s leading retail pharmacies, distributors and mail service providers.
