Patient's mother contacted dexcom on (b)(6) 2016 to report continuous glucose monitoring (cgm) inaccuracies compared to blood glucose (bg) meter that occurred on (b)(6) 2016.Sensor was inserted on (b)(6) 2016 into the arm.The dexcom g5 mobile continuous glucose monitoring system user's guide states: do not insert the sensor component of the dexcom g5 mobile system in a site other than the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years).The placement and insertion of the sensor component of the dexcom g5 mobile system is not approved for other sites.If placed in other areas, the dexcom g5 mobile system may not function properly.It was reported that the patient used an alternative blood glucose testing site.The dexcom g5 mobile continuous glucose monitoring system user's guide states: alternative site bg values from your arms, palm of your hand, etc., may be different and less accurate than your fingerstick bg values.Using alternative for calibration might affect sensor performance, resulting in you missing a severe low or high glucose event.At the time of contact, no injury or medical intervention was reported.
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