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Early Alert: Trividia Health Issues Correction for TRUE METRIX Blood Glucose Monitoring Systems
The FDA is aware that Trividia Health, Inc. has issued an Urgent Medical Device Correction to notify affected customers of corrections to the instructions of for use for all TRUE METRIX, TRUE METRIX AIR, and TRUE METRIX GO Self-Monitoring and TRUE METRIX PRO Professional Monitoring Blood Glucose Systems.
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.
As of January 16, Trividia Health has reported 114 serious injuries and one death associated with this issue.
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.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Trividia Health at trividia0126CC@trividiahealth.com or 1-888-835-2723.
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