Dexcom was made aware on 03/30/2017 that on (b)(6) 2017, after attempting to insert the sensor wire, it was noticed that it had detached and was laying next to the skin at the insertion site.The attempted sensor insertion was at the abdomen.No additional event or patient information is available.No product or data were provided for evaluation.The reported detached sensor wire could not be confirmed.A root cause could not be determined.
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Subsequent to the initial mdr, additional information was received on (b)(6) 2017 regarding an adverse event.On (b)(6) 2017, the patient's father stated that the patient's doctor's office suggested that the patient be taken to immediate care or to the emergency room (er) to check of the sensor wire could be stuck underneath the skin.The patient was seen by their doctor.The doctor stated that he did not find the sensor wire and that the insertion site was not infected.The patient was not given any medication for treatment.At the time of contact, the patient was doing fine.No additional event or patient information is available.
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