Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, the patient experienced a detached sensor wire.
The sensor was inserted into the leg on (b)(6) 2016.
The patient reported that upon removal of the sensor pod, the sensor wire remained in their leg.
On (b)(6) 2016, the patient had an x-ray performed that showed a staple sized fragment stuck in their leg.
Patient stated that they were in the process of locating a plastic surgeon to have the sensor wire removed.
Additional event or patient information is not available.
No product or data was returned for investigation.
The reported event of detached sensor wire was not confirmed.
A root cause could not be confirmed.
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.
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