Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, the patient experienced an adverse event.
The certified diabetes educator (cde) reported that they patient met with the patient at the doctor's office on (b)(6) 2017 regarding health insurance information for a trial device.
On (b)(6) 2017, the cde checked in with the patient and was informed that the patient had spent the night in the emergency room (er) on (b)(6) 2017.
The patient stated that the event involved his blood sugar and thinks that he had seizures.
The patient further stated that he was out cold when the event happened.
Additionally, it was indicated that at the time of contact, the patient was still wearing the dexcom system but there was no allegation against the trial device.
No additional patient or event information is available.
Data was provided for evaluation.
There was no allegation against the cgm that was reported, although the patient was wearing the system on the incident date.
Data investigation of the patient's studio data was conducted to review events on the date of incident.
A review of patient's diagnostic charts shows that the patient experienced estimated glucose values below 50 mg/dl and egvs over 375 mg/dl.
No root cause to be determined as there was no allegation against the system.
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