Unomedical reference number (b)(4).Event occurred in (b)(6).It was reported that the patient experienced high blood glucose levels and diabetic ketoacidosis due to a kinked cannula.She attempted to manually inject (mainly bolus delivery of less than 3 units) when she noticed she was going into diabetic ketoacidosis.Subsequently, on (b)(6) 2021, the patient went to the emergency room, with blood glucose level of more than 30 mmol/l where she was treated with an unspecified medication (drug name unknown) intravenously and fluids.Her health care professional did not identify her ketone level as dangerous/life threatening.She stayed there only for a short period of time, as her blood glucose levels had decreased significantly (around 10 mmol/l) but was still feeling unwell so was consequently admitted into hospital.The infusion set had been used for one day.During hospitalization, she was administered unspecified medication (drug name unknown) intravenously and manual injections as per the instructions from her health care professional as corrective treatment which resolved the issue.She was released from the hospital on (b)(6) 2021 with no permanent damage.However, on (b)(6) 2021 she was again admitted to the hospital and was currently hospitalized.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.
|