Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, there was a continuous glucose monitoring (cgm) inaccuracy compared to blood glucose (bg) meter that occurred.The sensor was inserted on the abdomen, on (b)(6) 2016.It was reported that the sensor was worn beyond seven days and that calibration was not performed after experiencing inaccuracies.No additional event or patient information is available.The receiver data log was reviewed on 12/23/2016.The complaint of inaccurate cgm values was confirmed.A root cause could not be determined.Labeling indicates: sensors may be worn for up to 7 days (168 hours).Also: if the cgm values are outside the 20/20 range, calibrate again.
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