Dexcom was made aware on (b)(4)2017 that on (b)(6)2017, there was an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter.The sensor was inserted into the abdomen on (b)(6)2017.Reportedly, the patient did not calibrate after the inaccuracy or enter finger stick values promptly.No additional event or patient information is available.No data was provided for evaluation.The reported inaccuracy could not be confirmed.A root cause could not be determined.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.Additionally, it was reported that the patient did not enter fingerstick values promptly into the cgm device.Labeling indicates: to calibrate the cgm system, do enter the exact blood glucose value that your blood glucose meter displays within 5 minutes of a carefully performed blood glucose measurement.Do not enter sensor glucose readings for calibration.Entering incorrect blood glucose values, blood glucose values obtained more than 5 minutes before entry, or sensor glucose readings might affect sensor accuracy and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.
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