Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017, the patient experienced an adverse event.Patient reports that he was at home on his recliner.Patient's continuous glucose monitor (cgm) was next to him.Patient alleges that the cgm did not alert for a low and experienced a hypoglycemic event.Patient's girlfriend found patient on his knees unresponsive.Patient's girlfriend called paramedics.When paramedic arrived, the patient was on his knees and the cgm was on the recliner.The ambulance picked up the patient, then the cgm alerted for an urgent low.Patient was treated with dextrose 50% and glucagon 15g.Patient's blood glucose (bg) was at 228 mg/dl when he was taken to emergency room.Additionally, the patient tested the alert function of the receiver and the audio alert did work.At time of contact, patient is well.No additional event or patient information is available.The device has been received for evaluation.A follow-up report will be submitted once the evaluation is complete.
|