WASHINGTON, D.C. — Diabetes patients who use certain TRUE METRIX blood glucose meters are being urged to review updated safety instructions after manufacturer Trividia Health issued an urgent labeling correction tied to one of the device’s error codes, saying the current wording could delay treatment during a dangerous high-blood-sugar event.
The company said the correction centers on the “E-5” error message displayed by all TRUE METRIX brand blood glucose monitoring systems, including TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO and TRUE METRIX PRO. The message can appear either when glucose levels exceed 600 mg/dL or when a test strip malfunction occurs, but officials warned the instructions may not have made clear that users with symptoms of severe hyperglycemia should seek immediate medical care.
As written, the booklet language could cause someone to troubleshoot the device instead of getting help, potentially delaying lifesaving treatment, according to the notice. Such delays, Trividia said, could lead to serious health consequences or death for people experiencing extremely high glucose levels.
Under the correction, users are now directed to seek medical attention right away if they see an E-5 code and feel symptoms associated with high blood sugar. The company said meters remain safe to use and products should not be returned or replaced, but customers should follow the updated guidance included in revised instructions and consumer communications.
The labeling update affects products sold widely in the U.S. and several international markets, including the United Kingdom, Mexico, Australia and parts of the Caribbean. The meters are also distributed through numerous retail and pharmacy store brands, meaning many consumers may use the systems without recognizing the TRUE METRIX name on the packaging.
Those co-branded versions include products sold through major chains and distributors such as CVS, Walgreens, Walmart’s ReliOn, Kroger, Rite Aid, Publix and others.
Trividia said it has notified the U.S. Food and Drug Administration of the action and is providing updated booklets and online materials.
