The tandem user guide states,? Make sure a sensor glucose reading shows in the upper right portion of the cgm home screen before calibrating.? No product was returned for evaluation. Should new relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
It was reported that there was an inaccuracy between the continuous glucose monitor (cgm) reading and the blood glucose (bg) meter reading. Reportedly, the cgm bg reading was 59 mg/dl, and the meter bg reading was 161 mg/dl. Reportedly, the customer entered calibration values during periods when no cgm values were present. No additional patient or event information was available. A root cause could not be determined. A replacement sensor was sent to the customer.
Patient Sequence No: 1, Text Type: D, B5