No product was returned for evaluation. Should new relevant information become available, a supplemental report will be submitted. Device not returned.
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 50 mg/dl, and the meter bg reading was 230 mg/dl. Additionally it was reported customer experienced continuous low blood glucose (bg) levels (values not provided). Cause was unknown. Bg was treated by consuming carbohydrates. 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