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 at the abdomen.Reportedly, calibration was not performed at least every 12 hours.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: calibrate at least once every 12 hours.Calibrating less often than every 12 hours might cause sensor glucose readings to be inaccurate, and you might miss a low or high blood glucose value.
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