Dexcom was made aware on (b)(6) 2017, that on (b)(6) 2017, the patient experienced intermittent audio output on the receiver, in addition to an adverse event that occurred.
The patient stated that on (b)(6) 2017 he had woke up about 5:35am, continuous glucose monitor (cgm) showed 87mg/dl, with a diagonal down arrow.
The patient's blood glucose (bg) meter tested at that time at 103mg/dl and the patient reports dosing a basal insulin.
The patient's cgm was under 50mg/dl at 6:15am, then went down to 37mg/dl.
The patient stated the cgm receiver vibrated but did not give audible alert.
The patient stated that he does not remember after that.
The patient stated that he had a seizure and fell on his side.
The patient's partner gave the patient glucagon, orange juice, and a peanut butter sandwich.
The patient's bg readings went up to 105mg/dl, then the patient's partner took the patient to the doctor's office where he was cared for by a nurse practitioner.
The patient had a shoulder x-ray performed, and they checked the patient's tongue, side, and head for trauma.
The patient was prescribed hydrocodone for pain, and a new glucagon prescription.
The patient was told to take alieve for inflammation, and to gargle with salt water for tongue injury.
At time of contact the patient's condition was he was home and ok.
No additional event or patient information is available.
|