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 abdomen on (b)(6) 2018.No data was provided for evaluation.Confirmation of the reported inaccuracy could not be determined.A probable cause could not be determined.Reportedly, the patient did not enter finger stick values promptly.Labeling indicates: to calibrate the system, enter the exact blood glucose value that your blood glucose meter displays within 5 minutes of a carefully performed blood glucose measurement.Entering incorrect blood glucose values or blood glucose values from more than 5 minutes before entry might affect sensor performance, and you might miss a low or high blood glucose value.No additional event or patient information is available.
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