The medtech giant warned that people using the Guardian Connect system to keep track of their blood sugar levels should update to the latest version of the mobile app as soon as possible.
Medtronic explained that patients have reported the app closing without warning, preventing them from receiving potential alerts associated with hypo- or hyperglycemic events. The company noted that it hasn’t yet received any reports of injury.
Guardian Connect users can remedy the situation by updating to the latest version of the app (v3.2.2), which can be found in the App store.
“As described in the patient’s App User Guide, Medtronic cannot guarantee that the iPhone will always allow for the Guardian Connect app to run in the background. If the iPhone automatically closes the Guardian Connect app, patients may receive a ‘Lost Communication’ alert. To ensure patients continue receiving sensor glucose data and alerts, we recommended that they periodically check that the Guardian Connect app is still running, being especially mindful when running several applications at once,” the company said.
Medtronic won FDA approval for its Guardian Connect CGM system in March this year. The company touts its system as the first connected standalone CGM designed to help people with diabetes avoid high and low glucose events.
Using Medtronic’s Guardian Sensor 3, the system alerts its users of potential high or low glucose events up to 60 minutes in advance. In one study, the Guardian Connect accurately alerted patients to 98.5% of all hypoglycemic events, according to Medtronic.
Steve MacMillan took over as CEO of Hologic in 2013, drawing on his experience at medtech titans like Stryker and Johnson & Johnson. Since then, Hologic has grown into a $3 billion business.
At DeviceTalks Boston, MacMillan will provide exclusive insights into the Massachusetts-based company and its evolving definition of women's healthcare. You don't want to miss it!
Use code WOMENSHEALTH to save an additional 10%.