Patient's mother contacted dexcom on (b)(6) 2015, to report a broken sensor wire that occurred on (b)(6) 2015.Sensor was inserted at the abdomen on (b)(6) 2015.Patient's mother reported that when the patient took off the sensor, the sensor wire was believed to be left in the patient's skin.During contact with dexcom, the patient removed the sensor wire and stated that it was broken in the skin.Patient's mother drove the patient to the emergency room (er).An x-ray of the abdomen was performed, and no fragments of the broken sensor wire were located under the skin.Additionally, it was reported that the transmitter was snapped into the sensor pod when the sensor was removed and no portion of the sensor wire is attached to the sensor pod.Patient's mother reported that the broken sensor wire is located 4-5 inches from the patient's belly button.Patient is not experiencing any additional discomfort at sensor insertion site.At the time of contact, patient was currently fine and resting at home.No additional event or patient information is available.No product or data was provided for investigation.The reported complaint cannot be confirmed.The root cause cannot be determined.
|