Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, detached sensor wires that were retained in the patient's skin.The initial sensor was inserted by the patient's clinician at the abdomen on (b)(6) 2016.Patient's grandmother reported that the initial sensor was removed on the same day it was inserted because the sensor failed to startup within 2 hours.Patient's grandmother reported that the sensor wire was not visualized on the skin side of the sensor pod when she removed the sensor, but visualized a sensor wire protruding out of the patient's abdomen upon sensor removal.Patient's grandmother reported that a second sensor was inserted after the initial sensor also had a detached sensor wire that was retained in the patient's skin.Patient's grandmother took patient to emergency room (er) on (b)(6) 2016.An x-ray exam confirmed (2) two retained sensor wires, on both sides of the abdomen.Patient's grandmother stated that the patient underwent a surgical procedure on (b)(6) 2016 to remove both sensor wires, which was successful.The grandmother reports that patient has recovered from surgery and denies all signs and symptoms of inflammation and infection.At the time of contact, patient home and doing great.No additional patient or event information was provided.No product or data was provided for investigation.The reported event could not be confirmed.The root cause could not be determined.
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