Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018, 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) 2018.Reportedly, the patient did not calibrate after the inaccuracy.No additional event or patient information is available.No data was provided for evaluation.The complaint confirmation and 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.
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