FDA warns about smartphone systems, glucose tests
Smartphone settings may cause notifications from diabetes devices to be missed, and some glucose and ketone meters were recalled.
The FDA issued two recent notices related to diabetes.
The agency warned patients with diabetes and their caregivers about the risk of missing alerts from smartphones connected to continuous glucose monitors, insulin pumps, automated insulin dosing systems, and other diabetes devices. Apps for these devices allow users to configure alert settings, and certain settings, such as notification permissions and “do not disturb” or “focus” modes, could cause alerts not to be received or noticed. The agency urged patients and caregivers to be cautious about connecting new hardware and updating operating systems on their phones. At least once a month, those using such devices should check that their alerts are working appropriately. Missed alerts can lead to serious harm, including severe hypoglycemia, severe hyperglycemia, diabetic ketoacidosis, and death, the FDA said.
The FDA also announced a class I recall from Nova Biomedical to correct StatStrip glucose and glucose/ketone hospital meters due to a software error that may cause incorrect glucose and/or ketone patient test results to be transmitted to hospital medical record systems. The issue may affect all historical test results before the meters are updated to v.0.0.13.45 software. There have been no reported injuries.