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.It was reported that the patient used an alternative skin site preparation.No data was provided for evaluation.The complaint confirmation and probable cause could not be determined.Labeling indicates: the sensor pod should stay on your skin using its own adhesive.But, if the patch is peeling up, you can use medical tape (such as blenderm¿, tegaderm¿, smith & nephew iv3000®, 3m¿ tape) for extra support.If you use tape, only tape over the white adhesive patch on all sides for even support.Do not tape over the transmitter or any of the plastic parts of the sensor pod.Do not tape under the sensor pod or leave any substance on the skin where you insert the sensor.No additional event or patient information is available.
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