Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, there was a continuous glucose monitoring (cgm) inaccuracy compared to blood glucose (bg) meter that occurred.The sensor was inserted on the arm, on (b)(6) 2016.No additional event or patient information is available.The receiver data log was reviewed on 12/23/2016.The complaint of inaccurate cgm values was confirmed.A root cause could not be determined.Labeling indicates: 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.
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