Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge.
Patient Sequence No: 1, Text Type: N, H10
Customer reported via phone call that they were hospitalized due to high blood glucose level and on (b)(6) 2020 with 900 mg/dl blood glucose value. The customer also mentioned blood glucose level of over 600 mg/dl and 536 mg/dl. The customer was treated with intravenous drip, pen and insulin pump. Customer did not report symptoms related high blood glucose level. Customer did allege insulin pump as under delivering. Drive support cap was normal. It was unknown whether the customer was using auto mode or not. Troubleshooting was declined by the customer for high blood glucose. The device will not be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5