Trividia Health, the Fort Lauderdale company behind the TRUE METRIX line of blood glucose monitors, is tightening up its instructions after a confusing error code was linked to serious injuries and one death. The firm has issued a labeling correction that spells out what users should do when their meter flashes an “E-5” warning, which can signal either a bad test strip or a dangerously high blood sugar level. Regulators say unclear guidance may have led some patients to delay urgent care, but Trividia says meters do not need to be returned and can stay in use with the updated instructions.
What the correction changes
According to the FDA, Trividia has revised the "Messages" section in the print owner’s booklets and on its online support materials. The new language makes it explicit that an E-5 code may mean either a test-strip problem or a very high blood glucose result above 600 mg/dL. It also stresses that anyone seeing an E-5 while experiencing hyperglycemic symptoms should seek medical help immediately.
Which meters and stores are affected
The correction covers the entire TRUE METRIX family, including TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO and TRUE METRIX PRO, along with co-branded and private-label versions. Per Trividia Health, the meters are sold under store and partner brands at major chains such as Walmart (Relion), CVS, Kroger, Publix, Walgreens and a range of other national and regional pharmacies.
The scope of the problem
Since the TRUE METRIX line launched in 2014, Trividia has reported 114 serious injury cases and one death associated with the E-5 error message, according to the Miami Herald. Company materials acknowledge that the previous wording could in some situations cause users to put off seeking emergency treatment.
What to do if your meter shows E-5
Under the updated guidance, users are instructed to test again right away with a new strip. If the E-5 message appears again and the person has symptoms such as fatigue, excessive urination, extreme thirst or blurred vision, Trividia advises getting medical attention without delay. If there are no symptoms, the company recommends retesting and calling Trividia’s customer care line at 1-888-835-2723 for help, according to Trividia Health.
Reporting problems and next steps
Trividia has instructed distributors and pharmacies to post the consumer notice and says it will notify customers as needed. The company maintains that products do not need to be returned or replaced. Anyone who believes they or a family member experienced a serious adverse event should contact a healthcare provider and file a report with FDA MedWatch, the agency’s adverse-event reporting program.
