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.It was reported that the patient calibrated during periods when cgm values were not present.No data was provided for evaluation.The complaint confirmation and probable cause could not be determined.Labeling indicates: do not calibrate if the out of range symbol shows in the status area.Do not calibrate if the glucose reading error symbol shows in the status area.No additional event or patient information is available.
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