Self-Monitoring Blood Glucose Meters Recalled Due to Potentially Defective Displays: FDA

Using the product could lead to a delay in treatment or therapy decisions, warned the agency.

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

Florida-based Trividia Health Inc. is recalling a limited number of blood glucose meters because of potentially defective liquid-crystal displays that could affect product performance, the company said in an Oct. 7 statement published by the Food and Drug Administration.

The recall applies to Trividia’s True Metrix self-monitoring glucose meters that are co-branded under the Good Neighbor Pharmacy brand. The affected items belong to lot number KD0746, printed on the side of the product box. They were manufactured on Sept. 4 and sold between Sept. 8 and 16 across the United States.

“It is possible that the LCD display for the affected products may show partial or missing numerical segments or characters or show ghosting (fading) of numerical segments or characters,” the company said. “As a result, it is possible that users could misinterpret a test result or experience a delay in obtaining test results. For users with low glucose (hypoglycemia), this could result in a delay in treatment or therapy decisions.”

According to Trividia, it has so far not received any reports of people suffering injuries as a result of using the recalled products.

The company said it was sending notifications to customers, including pharmacies, to inform them of the issue.

“If you have an affected Product, the Trividia Health Customer Care Department will help with return and replacement information,” it said.

Customers can contact Trividia’s customer care department by calling 1-888-835-2723 to check whether the product they have is part of the recall. Alternatively, customers may email the company at [email protected].

People can also visit www.trividiahealth.com/productnotice to check for recall eligibility.

Trividia clarified that customers can continue using the True Metrix Self-Monitoring Blood glucose meters for lots not included in the recall.

“Patient safety is our top priority at Trividia Health. This voluntary recall is being conducted in coordination with the U.S. Food and Drug Administration FDA to quickly resolve this matter,” the company said.

The Epoch Times reached out to Trividia for further comment but did not receive a response by publication time.

According to a blog post by law firm Morgan & Morgan, glucose devices can go wrong in many ways, such as hardware failures, algorithm or software issues, defects during manufacturing or sensor chemistry, and connectivity issues.

Some of the most common device failures include false high or low glucose level alerts, missed audible alarms due to speaker failures, and app notifications getting suppressed by settings on the smartphone, it said.

In February last year, the FDA issued a safety alert warning people not to use smartwatches or smart rings claiming to measure their blood glucose levels without piercing skin.

“These devices are different than smartwatch applications that display data from FDA-authorized blood glucose measuring devices that pierce the skin, like continuous glucose monitoring devices (CGMs),” the agency said at the time.

“The FDA has not authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own.”

The FDA warned that inaccurate glucose measurements can result in errors regarding managing the condition, including taking the wrong insulin dose or using medications to quickly bring down glucose levels.

“Taking too much of these medications can quickly lead to dangerously low glucose, leading to mental confusion, coma, or death within hours of the error,” the agency said.