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Trividia Health, Inc., has issued an Urgent Medical Device Correction regarding a specific displayed error message on TRUE METRIX brand glucose meters.
The “E-5” error code designates either a test strip error or a blood glucose value > 600 mg/dL. New instructions clarify that if the E-5 error appears and the patient is experiencing symptoms such as fatigue, excessive urination, thirst, or blurred vision, they should seek medical attention immediately.
As of January 16, Trividia Health has reported 114 serious injuries and one death associated with this issue.
“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,” according to the Trividia statement, which the FDA announced as an “early alert.”
If the device displays the E-5 message but the patient does not have hyperglycemia symptoms, they should retest with a new test strip. And if the error persists, they should call 1-800-803-6025 weekdays from 8 AM to 8 PM Eastern Standard Time for assistance.
Affected products are the TRUE METRIX, TRUE METRIX AIR, and TRUE METRIX GO Self-Monitoring, as well as TRUE METRIX PRO Professional Monitoring Blood Glucose Systems.
Healthcare professionals are advised to notify patients of the correction but that they can continue using the products.
In multiple patient facilities, the “Urgent Medical Device Correction” notice should be posted in areas where the products are stored within the facility so that all relevant personnel will see it.
The FDA says it will keep the public informed and will update its webpage as significant new information becomes available.
Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape Medical News, with other work appearing in the Washington Post, NPR’s Shots blog, and Diatribe. She is on X @MiriamETucker and BlueSky @miriametucker.bsky.social.
