Lilly case id: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event and a product complaint (pc), concerns a (b)(6)-year-old female (at the time of initial report) patient of unspecified origin.Medical history included cerebral infarction.Concomitant medication included acarbose and metformin for diabetes mellitus.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30) cartridge via reusable humapen ergo ii (humapen blue), 18 units before sleep, subcutaneously, for the treatment of diabetes mellitus, beginning approximately in 2009 (reportedly since more than ten years ago.On unspecified date, her blood glucose was unstable (preprandial blood glucose value was 8-9; postprandial blood glucose value was 13-15 and also postprandial blood glucose value was 17-18).Therefore, her physician increased her dose of human insulin isophane suspension 70%/human insulin 30% from 18 units before sleep to 20 units before sleep.Due to blood glucose increased, the complications was fundus hemorrhage and the eye did not see clearly.The events blood glucose increased and fundus hemorrhage were consider serious for being medically significant.On (b)(6) 2019, due to cerebral infarction she was hospitalized.No further information regarding hospitalization was provided.On (b)(6) 2019, due to cerebral infarction, she underwent stent and was discharged on (b)(6) 2019.On unspecified date, she not want to eat meal, stomach was not good and she was thinner 15 kg.On (b)(6) 2019, she was hospitalized due to hand and foot numbness.No further information regarding hospitalization was provided.On unspecified date hand and foot numbness was recovered.On (b)(6) 2019, she was discharged from hospital.On (b)(6) 2019, the pen body was damaged.Treatments for the remaining events and outcomes of the remaining events were not provided.Human insulin isophane suspension 70%/human insulin 30% was continued.The operator of the device was the patient and her training status was unknown.The general device model duration and the suspect device duration of use were noted to be more than 10 years ago (beginning around 2009).The suspect humapen ergo ii device was not returned to the manufacturer.The reporting consumer did not know if the events were related to human insulin isophane suspension 70%/human insulin 30% treatment or not.Update 18-jul-2019: information was received from the affiliate on 16-jul-2019.Tr number was received and pc was processed accordingly.No medically significant information was added to the case.Edit 24-jul-2019: upon internal review of the information received on 16-jul-2019, pc description was added in narrative, device age was updated to 10 years and improper use was updated from no to yes.Edit 24-jul-2019: case was reopened in order to add the corresponding fu date of the previous edit.No further changes were made.Update 05aug2019: upon further review of the adverse event and product complaint temporal relationship, (b)(4) could not have caused or contributed to the serious adverse event as the serious adverse event occurred prior to the pc; thus (b)(4) was reprocessed accordingly.Entered a device specific safety summary (dsss).Added medwatch and european and (b)(4) (eu/(b)(4)) fields for the suspect humapen ergo ii device, which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.
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