Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017, that the patient experienced continuous glucose monitoring (cgm) inaccuracies and a seizure.The sensor was inserted at the abdomen on (b)(6) 2017.At 3:00 am, patient confirmed her cgm blood glucose (bg) value at 159 mg/dl.Patient confirmed cgm bg at 6:15 am had a value of 99 mg/dl.Patient checked her finger stick (fs) value and it was 47 mg/dl, and she had a seizure.Patient reported convulsing and her mouth was foaming.Patient was treated for seizure with a glucose pen by her husband.Patient did not go to hospital.At the time of contact, patient is good.No additional patient or event information was provided.Data was provided for evaluation.The reported cgm inaccuracies was confirmed via data.The root cause could not be determined.The patient did not enter the bg meter values into the cgm device accurately.Labeling indicates: entering the wrong bg values, or waiting more than five minutes before entry, might affect sensor performance, resulting in you missing a severe low or high event.
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