Dexcom was made aware on (b)(6) 2016 that the patient experienced a detached sensor wire on (b)(6) 2016.The sensor was inserted into the arm on (b)(6) 2016.Patient's mother reported that upon removal of the sensor pod, she did not see the sensor wire.The patient was brought to the hospital for an ultrasound, which confirmed that the sensor wire was retained within 1 centimeter of skin surface in subcutaneous fat and above muscle.It was indicated that there was a plan to surgically remove the sensor wire as it was causing discomfort.The patient has hypersensitivity to metal and patient's parent believes this is what is causing the discomfort in the site of the retained wire.No further event information is available.The sensor applicator was provided for evaluation.However, an investigation could not be performed due to no sensor/sensor wire being returned.Additionally, a copy of the ultrasound was not provided to dexcom.The reported event of detached sensor wire could not be confirmed.A root cause could not be determined.The sensor was inserted into the arm.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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