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

Detected February 26th, 2026

Summary

The FDA issued an Early Alert regarding Trividia Health's correction of TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO, and TRUE METRIX PRO Blood Glucose Monitoring Systems due to reports of injuries and death. The correction updates instructions for the E-5 error code, which indicates very high blood glucose results or test strip errors.

View original document View source feed page

What changed

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.

Source document (simplified)

CDRH is issuing this Early Alert **to notify the public of a potentially high-risk device issue.* The FDA will keep the public informed and update this web page as significant new information becomes available.*

Affected Product

The FDA is aware that Trividia Health, Inc. has issued an Urgent Medical Device Correction to notify affected customers that all TRUE METRIX, TRUE METRIX AIR, and TRUE METRIX GO Self-Monitoring and TRUE METRIX PRO Professional Monitoring Blood Glucose Systems have updated use instructions. Affected devices:

TRUE METRIX Self-Monitoring Blood Glucose System
TRUE METRIX AIR Self-Monitoring Blood Glucose System
TRUE METRIX GO Self-Monitoring Blood Glucose System
TRUE METRIX PRO Professional Monitoring Blood Glucose System Full List of Affected Product

What to Do

If you or your patient receive an E-5 error code and are experiencing symptoms of high glucose, seek medical attention immediately.

On February 6, 2026, Trividia Health sent all affected customers a letter recommending the following actions:

People with Diabetes: Please follow the updated E-5 error code instructions in the “Urgent Medical Device Correction” consumer notice or visit www.trividiahealth.com for links to the updated Owner’s Booklets and help resources. You may continue to use the TRUE METRIX Products. Products are not to be returned or replaced.
Health Care Professionals: Immediately notify your patients of this correction. You may use the “Urgent Medical Device Correction” consumer notice. Patients may continue to use the TRUE METRIX Products.
- For multiple patient facilities, immediately post the “URGENT MEDICAL DEVICE CORRECTION” HCP notice in areas where the products are stored within your facility to notify personnel of this labeling correction.
Distributors, Pharmacists, DME Providers, and Mail Order/eCommerce Providers: Immediately notify your customers, stores and providers of this correction. Include the Urgent Medical Device Correction letter in your notification and ask that they notify their customers or facilities if they have further distributed the affected products. Customers may continue to purchase and use the TRUE METRIX Products. Products are not to be returned or replaced.
- Retail Pharmacies: Post the “Urgent Medical Device Correction” consumer notice in areas where the Products are sold to notify patients of this labeling correction. Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

Updated E-5 Instructions for TRUE METRIX, TRUE METRIX AIR, and TRUE METRIX GO:

| Display | Reason | Action |
| --- | --- | --- |
| | Very High blood glucose result (higher than 600 mg/dL),
Or Test Strip Error | WARNING!!
Retest with a new test strip.
If the error persists and you have symptoms such as fatigue, excess urination, thirst, or blurry vision, seek medical attention immediately.

If you are not experiencing symptoms, retest with a new test strip. If the error persists, call 1-800-803-6025, Monday-Friday, 8AM-8PM EST for assistance. |
Updated E-5 Instructions for TRUE METRIX PRO:

| Display | Reason | Action |
| --- | --- | --- |
| | Very High blood glucose result (higher than 600 mg/dL),
Or Test Strip Error | WARNING!!
Retest with a new test strip.
If the error persists and the patient has symptoms such as fatigue, excess urination, thirst, or blurry vision, seek medical attention immediately.

If the patient has no symptoms, retest with a new test strip. If the error persists, call 1-800-803-6025, Monday-Friday, 8AM-8PM EST for assistance. |

Reason for Early Alert

Trividia is correcting the E-5 Error Code in the “Messages” section of the Owner’s Booklets/System Instructions for Use and the online labeling and help guides.

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 are experiencing symptoms of high glucose. A delay in treatment may result in serious adverse health consequences, such as dehydration, altered mental status, or death, especially for users with very high blood glucose levels.

Trividia is updating the recommended E-5 Error Code actions in the TRUE METRIX device labeling 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 will notify users of additional mitigation strategies as needed.

As of January 16, Trividia Health has reported 114 serious injuries and one death associated with this issue.

Device Use

The TRUE METRIX devices are used for the quantitative measurement of glucose (sugar) in fresh whole blood samples.

Contact Information

Health Care Professionals and patients in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Trividia Health at trividia0126CC@trividiahealth.com or 1-888-835-2723. Distributors, pharmacists, DME providers, and mail order/eCommerce providers in the U.S. with quality problems or questions about this issue should contact Trividia Health at trividia0126CS@trividiahealth.com or 1-800-588-1685.

Additional Company Resources

Company-provided information is posted here by the FDA as a public service.

Firm Press Release [02/06/2026]
Firm-Issued Medical Device Correction Letter [02/06/2026]
Firm List of Impacted Products [02/06/2026]
Firm Medical Device Web Page

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.