Distributor contacted dexcom on (b)(6) 2016 to report on behalf of patient a detached sensor wire that occurred on (b)(6) 2016.The sensor was inserted into the abdomen on (b)(6) 2016.Nurse removed sensor wire from the patient and upon its removal, did not see the sensor wire attached to the sensor pod.Nurse thought she did something incorrectly and inserted a new sensor.On (b)(6) 2016, about one month after the first sensor insertion, the patient went into the hospital for a consultation and a nurse realized there was a mass under the patient's skin.Patient did not have any symptoms and the skin was not red or inflamed.The doctor performed an ultrasound which confirmed the wire filament placed under the skin.As of (b)(6) 2016 the sensor wire had not been removed.No additional event or patient information was provided.The patient using the device is under two years old.The dexcom g4 platinum continuous glucose monitoring system states: the dexcom g4 platinum continuous glucose monitoring (cgm) system is a glucose monitoring system indicated for detecting trends and tracking patterns in persons (age 2 years and older) with diabetes.
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