Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, a needle retraction issue occurred.The sensor was inserted into the arm on (b)(6) 2018.No product or data was provided for evaluation.Confirmation of the problem and probable cause could not be determined.Labeling indicates: all patients can use their bellies (abdomen).Patients 2 to 17 years old can also choose their upper buttocks.Look for a place on your belly or upper buttocks where you have some padding.The sensor is not tested or approved for other sites.Talk to your hcp about the best site for you.No additional event or patient information is available.
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