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……