Unomedical reference number (b)(4).Event occurred in the united states.It was reported that the patient faced a bent cannula due to which she experienced high blood glucose level.Therefore, they tried to treat it with multiple daily injection, but on (b)(6) 2023, the patient first went to the emergency room and was subsequently admitted to the hospital due to high blood glucose level.Her highest blood glucose level was above 500 mg/dl and ketone levels were high.During hospitalization, the patient received fluids of saline, insulin, and unspecified medication (drug name unknown) intravenously as corrective treatment which resolved the issue.On (b)(6) 2023, the patient was released from the hospital with no permanent damage.Moreover, this similar issue occurred on (b)(6) 2023, (b)(6) 2023 and (b)(6) 2024 with three same type of infusion set cannula where the cannula was kinked, and issue was noticed three or more hours after insertion.Further, the infusion had been used for 24 hours and the site location was patient's abdomen.She had small ketones ketone level which her healthcare professional did not assess as dangerous or life-threatening.She tried to treat with correction injection via multiple daily injection.The patient replaced the infusion set and insulin was resumed successfully.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 was available.
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