Patient contacted dexcom on (b)(6) 2015 to report continuous glucose monitoring (cgm) inaccuracies compared to blood glucose (bg) meter that occurred on (b)(6) 2015.The sensor was inserted on (b)(6) 2015.It was reported the patient did not calibrate accordingly.At the time of contact, no injury or medical intervention was reported.The complaint device was not returned for evaluation and data was not provided; therefore, the reported complaint of inaccuracies cannot be confirmed.It was also reported that the patient did not calibrate since seeing the inaccuracy.It should be noted that the dexcom g4 platinum continuous glucose monitoring system user's guide states: 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.However, a root cause for the reported inaccuracy cannot be determined.
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