Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017, the patient experienced a broken sensor wire.The sensor was inserted at the right thigh on (b)(6) 2017.Patient's reported that upon removal of the sensor pod, he did not see the sensor wire.Patient visited the primary care doctor on (b)(6) 2017.An x-ray confirmed that 3 centimeters of wire was under the skin.At time of contact, patient is stable and still using the continuous glucose monitor.No additional event or patient information is available no product or data was provided for investigation.The reported issue could not be confirmed.The root cause could not be determined.The sensor was inserted into the thigh.Labeling indicates: do not insert the sensor in sites other than the belly (abdomen) or upper buttocks.Use in other sites might cause sensor glucose readings to be inaccurate and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.
|