Patient Sequence No: 1, Text Type: N, H10
It was reported that an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter occurred. The sensor was inserted into the abdomen on (b)(6) 2020. No data was provided for evaluation. Confirmation of the allegation and a probable cause could not be determined. The reported glucose values fall within the d zone of the parkes error grid. The data investigation did not find blood glucose calibration values to compare to cgm values during the reported sensor session or the calibrations during the reported sensor session were in accurate range per device specifications. No injury or medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5