Unomedical reference number (b)(4).Event occurred in (b)(6).It was reported that the patient experienced high blood glucose levels and diabetic ketoacidosis.Further, she attempted to manually inject when she noticed she was going into diabetic ketoacidosis.The infusion set had been used for three days.Subsequently, on (b)(6) 2021, she went to the emergency room, with blood glucose level of more than 40 mmol/l which was due to a kinked cannula, where she was treated for her diabetic ketoacidosis (as she shad ketones) through insulin infusion, potassium and glucose while being admitted into hospital.She stayed in the emergency room for a few hours and left from there with blood glucose levels between 8 and 14 mmol/l.Consequently, on the same day ((b)(6) 2021), she was admitted to the hospital as she was still unwell.During hospitalization, she was administered insulin infusion, glucose and potassium as corrective treatment which resolved the issue.On (b)(6) 2021, she was released from the hospital with no permanent damage.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information available.
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