Product Info

Of the 138 adverse events reported through the end of the study period, 39%
(N=54) were classified as device related, including glycemic events (severe
hyperglycemia) and skin issues (abscess, dermatitis, skin infection at the infusion
set site and skin irritation). Of the 54 device-related adverse events, 49 were severe
hyperglycemia events that were thought to be device related. There were no
procedure related events.
There were 86 reports of severe hyperglycemia and there was no diabetic
ketoacidosis while on the MiniMed 670G System during the study. The majority of
these severe hyperglycemic events (81/86) were mild in intensity. Ketone levels
were available for 83 of the 86 severe hyperglycemia episodes and the majority of
ketone levels (57/86) were low (0.6–1.5 mmol/L).
Of the 49 device related episodes of severe hyperglycemia, 46 were believed to be
due to infusion set issues such as occlusion, bent cannula or cannula pull out.
These issues are typically seen in relatively high rates in the pediatric population
(causes provided in Table G-1 and Table G-2). Unlike insulin pump therapy which
may or may not have alerts associated with infusion set failure, the MiniMed 670G
System has fixed alarms (high alerts) that serve as an additional mitigation for
subjects.
Table G-1. Run in Period Severe Hyperglycemia:
Cause Total
Infusion set change 9
Occlusion alarm 0
Infusion set fell out 0
Bent or Kinked Cannula 0
Total 9
Table G-2. Study Period Severe Hyperglycemia
Cause Total
Infusion set change 29
Occlusion alarm 3
Infusion set fell out 2
Bent or Kinked Cannula 1
Infusion set change or safe basal 1
Safe basal 1
Suspend before low suspension 1
Automatic & manual suspensions 1
Total 39
374 Chapter 17