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 experienced high blood glucose level of 400 mg/dl. The customer treated high blood glucose level with insulin pump. The current blood glucose level was 393 and 382 mg/dl. The customer's blood glucose went high at 4pm with 300 mg/dl since then it went up to the 449 mg/dl. The customer was using insulin pump system within 48 hours of reported high blood glucose event. Customer was neither in emergency room, nor admitted into hospital due to high blood glucose. Based on customer report proceed in troubleshooting customer alleged the possible insulin pump under delivery. Auto mode feature was not active and not automatically adjusting insulin at time of event. The insulin pump will not be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5