Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, the patient experienced continuous glucose monitoring (cgm) inaccuracies compared to blood glucose (bg) meter and a low event.The sensor was inserted on (b)(6) 2016.It was reported that the patient's parents noticed that the sensor kept giving readings which were different from that of the bg meter - some readings were just slightly out, while others were significantly out.Patient's parents attempted to recalibrate the cgm but the readings continued to be different from the bg meter.Patient stated that he was feeling low and was very tired and lethargic.Patient had a fingerstick measurement performed which confirmed that they were at 2.5mmol/l.The low alarm had not alerted the patient to the low, as the dexcom was showing a value of 4.5mmol/l.Patient's mother managed to raise the patient's bg levels.At the time of contact, the patient was fine.Additional event or patient information is not available.Data was provided for evaluation.The reported event of inaccurate cgm readings was confirmed.A root cause could not be determined.
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