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 leg on (b)(6) 2018.Reportedly, the patient used an expired sensor.No data was provided for evaluation.The complaint confirmation and probable cause could not be determined.Labeling indicates: sensor placement and insertion is not approved for sites other than the belly (abdomen).Labeling indicates: do not insert sensors past the expiration date.The expiration date format is yyyy-mm-dd.Insert sensors on or before the end of the calendar day printed on the sensor package label.No additional event or patient information is available.
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