Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2016, the patient experienced an adverse event.Date of issue is an approximation.It was reported that the patient experienced hypoglycemic episodes and on 4 occasions, the paramedics were called to her house.It is unclear of what the issue with the dexcom continuous glucose monitor (cgm) was at the time of event.No additional patient or event information is available.Reportedly, the patient used cgm while pregnant against user guide recommendations.Labeling indicates: the dexcom system is not approved for use in children or adolescents, pregnant women or persons on dialysis.No data or product was provided for evaluation.The complaint confirmation was unable to be determined.A root cause was not determined.
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