Blood Glucose Monitoring Systems

  • As currently written, the Owner’s Booklets/System Instructions for Use 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.
  • Company: Trividia Health, Inc.
  • Medical Devices
  • FDA
  • February 6, 2026

Product details

  • Blood Glucose Monitoring Systems

Company announcement

Trividia Health, Inc. is initiating a labeling correction for TRUE METRIX Blood Glucose Monitoring Systems.

The correction updates the E-5 Error Code instructions in the Owner’s Booklets/System Instructions for Use to emphasize seeking immediate medical attention when experiencing symptoms of high glucose.

The affected products were distributed in the United States, United Kingdom, Mexico, Australia, and the Caribbean.

Since August 2014, there have been 114 reported serious injuries, and one death associated with the E-5 Error Code.

Risk:

A delay in treatment may result in serious adverse health consequences or death, especially for users with very high blood glucose levels.

Impacted states: Nationwide

Products:

- TRUE METRIX Blood Glucose Monitoring Systems

- TRUE METRIX AIR Blood Glucose Monitoring Systems

- TRUE METRIX GO Blood Glucose Monitoring Systems

- TRUE METRIX PRO Blood Glucose Monitoring Systems

Contact

For more information, call 1-888-835-2723.

View the original FDA notice

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