Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017, that the patient's sensor fell off while he slept during the night and patient experienced a hypoglycemic event.Patient's symptom also was described as fainting.The sensor was inserted at the abdomen on (b)(6) 2017.The patient's dogs realized the hyperglycemic event and began to bark.Patient's wife was awakened by the barking dogs.Patient's wife treated patient with glucagon and called for an ambulance.The ambulance and staff arrived and administered glucose to the patient.Patient was not transported to hospital.Patient did not contact an emergency physician.No glucose values were provided.At the time of contact, patient is feeling well.No additional patient or event information was provided.No product or data was provided for investigation.The reported event could not be confirmed.The root cause could not be determined.The patient did not clean the area before applying the sensor.Labeling indicates: clean your sensor placement site with an alcohol wipe to prevent infections.If your insertion site is not clean and completely dry, you run the risk of infection or the sensor pod not sticking and falling off.
|