Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, that 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) 2017.The patient was at work and stated that they felt faint shortly before they passed out.The patient's colleagues called the ambulance and when the paramedics arrived, they administered the patient with 1 mg glucagon injection.It was indicated that the patient treated themselves with additional sugars such as a cup of tea with 2 teaspoons of sugar and a kit-kat chocolate biscuit because they felt like they needed it.The patient was not taken to the hospital and was sent home from work.At the time of contact, the patient was still feeling weak but was at home resting.No additional patient or event information is available.No data was provided for evaluation.The reported event of inaccuracies could not be determined.A root cause could not be determined.It was reported that the patient did not calibrate after the inaccuracy.Dexcom labeling indicates: if the difference between your sensor glucose reading and blood glucose value is greater than 20% of the blood glucose value for sensor glucose readings > 80 mg/dl or greater than 20 points for sensor glucose readings < 80 mg/dl, wash your hands and take another blood glucose measurement.If the difference between this second blood glucose measurement and the sensor is still greater than 20% for sensor glucose readings > 80 mg/dl or greater than 20 points for sensor glucose readings < 80 mg/dl, recalibrate your sensor using the second blood glucose value.The sensor glucose reading will correct over the next 15 minutes.It was reported that the patient was taking medication containing acetaminophen.Dexcom labeling indicates: make sure you have not taken any medications containing acetaminophen (such as tylenol).
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