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.No data was provided for evaluation.The complaint confirmation and probable cause could not be determined.Labeling indicates: do not insert the sensor component of the 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 g5 mobile system is not approved for other sites.If placed in other areas, the g5 mobile system may not function properly.No additional event or patient information is available.
|