Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, a missing sensor wire occurred.The sensor was inserted into the arm on (b)(6) 2018.Reportedly, the transmitter was not fully snapped into the sensor pod.No medical intervention was reported.Additional event or patient information is not available.No product was provided for evaluation.The complaint confirmation was unable to be determined.A root cause could not be determined.Labeling indicates: sensor placement and insertion is not approved for sites other than the belly (abdomen).Labeling indicates: make sure you hear 2 clicks when you snap the transmitter in place.If it is not fully snapped in, this may lead to a poor connection and let fluids to get under the transmitter.This can lead to inaccurate sensor glucose readings.
|