Early Alert: Trividia Health Issues Correction for TRUE METRIX Blood Glucose Monitoring Systems
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
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!! 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!! 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
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