Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017 the sensor wire was missing.The attempted sensor insertion was at the leg.Reportedly, the patient removed the transmitter prior to removing the sensor pod.No additional event or patient information is available.No product or data were provided for evaluation.The reported missing sensor wire could not be 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.Labeling indicates: do not remove the transmitter before removing the sensor pod from your body.
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Subsequent to the initial mdr, dexcom received additional information on 03/15/2017 regarding an adverse event.The patient contacted their physician on (b)(6) 2017 and stated that they inserted the sensor into their thigh.It was reported that the sensor did not start up nor function.The patient did not visualize the sensor wire at the skin side of the sensor pod when they removed the sensor pod from their thigh.The patient believes that the sensor wire is retained because when they touch their thigh in the area where the sensor was worn, they could feel something under their skin.At the time of contact with their physician, the patient did not report any signs or symptoms of inflammation or infection.There were no x-rays taken and no treatment was provided as the patient was not seen by their physician.No additional event or patient information is available.
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