Lilly case id: (b)(4).This report is associated with product compliant: pending.This spontaneous case, reported by a consumer, who contacted the company to ask for information, concerns an adult female patient of unknown age and origin.Medical history was not provided.Concomitant medication included: insulin glargine for unknown indication for use.The patient received human insulin (rdna origin) regular (unknown manufacturer), via humapen luxura, unknown body type, 2 iu, when the patient s glycemia was high, unknown route of administration, for type 1 diabetes mellitus, starting in the beginning of 2018.On an unspecified date, unknown time after beginning human insulin, the patient experienced muscular pain in shoulders.She underwent red blood cell sedimentation rate test, which was altered (no values provided), the patient s rheumatoid factor was at 16 (reference range: up to 8; no unit was provided) and she underwent a shoulder ultrasound, which was normal.On unknown date, the patient was diagnosed with arthritis.As corrective treatment, the patient received unspecified antibiotic, ketorolac tromethamine and metamizole sodium.It was also reported that the patient was experiencing difficulty to control her glycemia.On unspecified date, the patient s glycemia was between 270 and 290 (no unit and reference range provided).Due to these events, the patient was hospitalized on (b)(6) 2018.To control the patient's glycemia, the dose of insulin glargine was gradually increased to 60 iu, 70 iu and 80 iu, which was ongoing.Also, when the patient s glycemia exceeded 300, the human insulin r dose was 8 iu daily and if the glycemia was under 300 the dose was 6 iu.The patient also was prescribed metformin as corrective treatment.The patient was discharged from hospital on (b)(6) 2019.The patient s glycemia was more controlled (fasting blood glucose was between 140 and 156 and after lunch it was 190) and the pain in shoulders ceased.Information regarding laboratorial examination, corrective treatments and event outcome was not provided.The human insulin regular therapy status was not provided.Who was the operator of the device and the training status was not provided.This device model and the reported device have been used for unknown period of time (reported to be expired).The device was not expected to return since there was no associated product complaint.The reporting consumer did not provide an opinion of relatedness.Edit (b)(6) 2019: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.
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