Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017, the g5 mobile application had intermittent audio output and patient experienced an adverse event.
Patient's wife reported that the patient did not hear the low alert.
Patient was found having seizures and a blood glucose (bg) of 30 mg/dl.
A 911 call was made.
Emergency medical technicians (emts) arrived and treated patient with 15 grams of glucose.
At time of contact, patient is stable.
No additional event or patient information was provided.
Data was provided for evaluation.
Patient entered a calibration at 04:25am utc.
The calibration was not accepted as did not meet the minimum value requirement of >40 mg/dl.
Patient had entered 33 mg/dl g5 mobile application responded with a displayed message prompting to enter another bg value.
A calibration was successfully entered at 07:35am utc upon which the patient's g5 mobile application displayed a value and audibly gave a low alert.
It is between the time of 04:25am utc and 07:35am utc that the patient alleges the adverse event took place, during this time no alert was given for the low glucose due to the g5 mobile application not displaying any values during its request for an additional calibration.
The reported no audio alert was confirmed via data.
The root cause was determined to be patient misuse/error.
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