Investigations showed that the customer was potentially using sg values for bg calibration on previous day of event likely leading to inaccurate sensor glucose values, subsequently affecting the ability of the system to predict any potential medical event.This is not the intended use of the device.As per notes, user was symptomatic, feeling fatigue, urinarily discomfort, shortness of breath and thirst and had to go to the doctor's office, so hcp becomes aware of the event.Hcp provided medical assistance to solve the event and was treated with 20 units of insulin but no hospitalization was required.As per notes, user took 10 units of insulin and at 3:57 pm the bgm reading went down to 392 mg/dl, then at 4:20 pm it was 342 mg/dl.User went home afterwards and felt better.H3.Device evaluated by manufacturer? yes.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 19.
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