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 patient used an alternate blood glucose testing site (site other than fingertips) and that the dexcom system was not calibrated at least every 12 hours.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: do not use alternative blood glucose site testing (blood from your palm or forearm, etc.) for calibration.Alternative site blood glucose values may be different than those taken from a fingerstick blood glucose value and may not represent the timeliest blood glucose value.Use a blood glucose value taken only from a fingerstick for calibration.Alternative site blood glucose values might affect the dexcom g5 mobile cgm system's accuracy.Also: calibrating less often than every 12 hours might cause sensor glucose readings to be inaccurate, resulting in you missing a severe low or high glucose event.
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