Unomedical reference number (b)(4).Event occurred in the united states.It was reported that the patient's infusion set's cannula was bent and had a possible infection due to which she experienced high blood glucose level of 900 mg/dl and had high ketone levels.Therefore, the patient removed the infusion set.Subsequently, the patient went to the emergency room and was admitted to the hospital.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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