Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, there was an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter.The sensor was inserted into the abdomen on (b)(6) 2018.Reportedly, calibrations were entered during periods of rapid rate of change.Reportedly, calibrations were entered during periods when cgm values were not present.No additional event or patient information is available.No data was provided for evaluation.The complaint confirmation of the reported inaccuracy could not be determined.A root cause could not be determined.Labeling indicates: do not calibrate if your blood glucose is changing at a significant rate, typically more than 2 mg/dl per minute.Do not calibrate when your receiver screen is showing the rising or falling single arrow or double arrow, which indicates that your blood glucose is rapidly rising or falling.Calibrating during rapid rise or fall of blood glucose may affect sensor accuracy.Labeling indicates: don't calibrate.Wait 10 minutes.Move display device and transmitter within 20 feet of each other without obstruction.Wait another 10 minutes.Labeling indicates: when your display device has system errors, you may not receive any sensor glucose readings and you should not calibrate.
|