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 they started to feel shaky and the cgm was displaying a value of 4.5mmol/l.The patient checked her bg reading and the meter displayed 2.2mmol/dl.The patient took 300ml of apple juice and about an hour later, they're bg levels were back to normal around 5.0 mmol/l.At the time of contact, the patient was doing fine.No additional patient or event information is available.Data was received for evaluation; data review confirmed the reported event of inaccurate cgm values.A root cause could not be determined via data.
|