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
The customer reported via phone call that they were hospitalized due to high blood glucose, diabetic keto acidosis, pneumonia, possible heart attack on (b)(6) 2020 with blood glucose level was 440 mg/dl and in the in range of 400 mg/dl. Customer had been using insulin pump system within 48 hours of reported high blood glucose event. The customer was treated with insulin pump and was admitted to emergency room. Customer was using auto mode. Customer declined troubleshooting for high blood glucose level. The insulin pump will be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5