Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, the patient experienced an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter and an adverse event.The sensor was inserted into the abdomen on (b)(6) 2018.The patient stated he measured his blood sugar before driving home and the cgm was displaying 100 mg/dl.When he arrived at home, he passed out in the garage and fell into a coma.The patient's friend found him and called an emergency doctor and the doctor administered the patient with glucagon injections.The patient indicated that his blood sugar was measured at 34mg/dl and did not fell any symptoms prior to passing out.At the time of contact, the patient was doing well.No additional patient or event information is available.No product or data was provided for investigation.Confirmation of the complaint was undetermined.The root cause could not be determined.
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