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 arm on (b)(4) 2018.Reportedly, the patient wore the sensor beyond seven days.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: your sensor gives you sensor glucose readings for up to seven days.The performance of a sensor has not been tested beyond seven days.
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