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Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), additional information was received from second reporter, concerned a (b)(6)-year-old asian male patient.Medical history included hypertension, arteriosclerosis, leg numbness and allergy to penicillin.His elder sister had diabetes and father was allergic to penicillin.Concomitant medications included acarbose and metformin for diabetes mellitus and epalrestat for unknown indication.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog mix 50) with unknown formulation via a reusable device huma pen ii (humapen ergo ii) at an unknown dose and frequency subcutaneously for treatment of the type ii diabetes mellitus beginning in 2018.On an unknown date while taking insulin lispro protamine suspension 50%/insulin lispro 50% treatment he had bad blood glucose level and fasting blood glucose was more than 20 (units and reference range were not provided) due to which he was hospitalized for regulating blood glucose level.After hospitalization on physician advice he switched to insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix 25), via cartridge, twice a day (morning 26 iu, night 16 iu), subcutaneously, for the type ii diabetes mellitus, beginning approximately on (b)(6) 2019.On an unknown date, when injecting insulin lispro protamine suspension 75%/insulin lispro 25%, it was very painful when the injection pen pushed in.It was noted the injection button of the humapen ergo ii was not very flexible and it was pushed down very slowly during injection (product complaint (b)(4) /lot number unknown).Information regarding any further hospitalization details, corrective treatments, outcome of the events was not provided.Insulin lispro protamine suspension 75%/insulin lispro 25% treatment was continued.It was unknown if he would re-start insulin lispro protamine suspension 50%/insulin lispro 50% treatment or not.The operator of the device and his/her training status was not reported.The general humapen ii model duration of use and suspect device model duration of use was around six months.The suspect humapen ergo ii device associated with product complaint (b)(4) was not returned to the manufacturer.The reporting consumer did not provide a relatedness assessment between the events and insulin lispro protamine suspension 75%/insulin lispro 25% and insulin lispro protamine suspension 50%/insulin lispro 50% treatments or humapen ii device.Update 07-jun-2019: this case was determined to be non-valid since there was no identifiable valid adverse event reported.Update 17-jun-2019: the case was downgraded to non-serious and became valid after additional information was received on (b)(6) 2019 from second reporter via psp.Added a new reporter, all medical histories, three concomitant medications and weight, height of patient.Added a suspect medication humalog 25 and suspect device.Deleted the suspect humalog 50 and added in historical medication.Deleted the serious event of hospitalization and added a non-serious event of injection site pain.Updated the narrative with new information.Update 21-jun-2019: additional information was received on (b)(6) 2019 from rcp regarding pc number (b)(4).The action item to monitor pc was set accordingly.No new medically significant information was received and no changes were done to the case.Update 12-jul-2019: additional information was received from the initial reporter via the psp on 10-jul-2019.This case was upgraded to serious (p1) due to addition of serious event of fasting blood glucose increased due to hospitalization and associated with reusable device humapen ergo ii.Added new suspect with insulin lispro protamine suspension 50%/insulin lispro 50% treatment with associated serious event of fasting blood glucose increased and deleted from historical medication and lab test with fasting blood glucose with values of more than 20.Updated eu/(b)(4) field of reusable device humapen ergo ii, causality statement and narrative with new information.Edit 18jul2019: updated medwatch fields for expedited device reporting.No new information added.Update 22jul2019: additional information received on 22jul2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the european and (b)(4) (eu/(b)(4)) device information for the suspect humapen ergo ii device associated with product complaint (b)(4), which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.
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Lilly case id: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), additional information was received from second reporter via psp, concerned a 56-year-old asian male patient.Medical history included hypertension, leg arteriosclerosis, leg numbness and allergy to penicillin.His eldest sister had type-1 diabetes, blood sugar of second elder sister was high, one elder sister could not see clearly, could not hear clearly and father was allergic to penicillin.Concomitant medications included acarbose (branded and generic) and metformin for diabetes mellitus and epalrestat for unknown indication.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog mix 50) with unknown formulation via a reusable device humapen ii (humapen ergo ii) at an unknown dose and frequency, subcutaneously for treatment of the type ii diabetes mellitus, beginning in 2018.On an unknown date while taking insulin lispro protamine suspension 50%/insulin lispro 50% treatment, he had bad blood glucose level and fasting blood glucose was more than 20 (units and reference range were not provided) due to which he was hospitalized for regulating blood glucose level.After hospitalization on physician advice, he switched to insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injection (humalog mix 25, 100u/ml), via cartridge via a reusable device humapen ii (humapen ergo ii), twice a day (morning 26 iu, night 16 iu), subcutaneously, for the type ii diabetes mellitus, beginning approximately on (b)(6)2019 (conflicting information was provided by the reporter).In (b)(6)2019, after starting insulin lispro protamine suspension 75%/insulin lispro 25% therapy, all over the body tingling, walking shaking, numbness of hands and feet.On an unknown date, when injecting insulin lispro protamine suspension 75%/insulin lispro 25%, it was very painful when the injection pen pushed in.It was noted the injection button of the humapen ergo ii was not very flexible and it was pushed down very slowly during injection (product complaint (b)(4)/lot number unknown).On an unknown date (few weeks from the time of reporting on 09-jan-2020), there were situations of high blood sugar, confusion and walking shaking.The blood sugar value was 30-40 (no units and reference range was provided).The event of high blood sugar (second episode) was considered serious due to its medical significance.On an unknown date, there were situations that sleep was not good (insomnia) and eyes could not see clearly.He received calcium dobesilate for the treatment of eyes could not see clearly and an unspecified hypnotics for the treatment of insomnia.On (b)(6)2020, the blood sugar was high (the blood sugar value was 28.4).He was uncomfortable.As of (b)(6)2020, the dosage of insulin lispro protamine suspension 75%/insulin lispro 25% was 22units in morning and 14units in night.He did not recover from the events of high blood sugar (second episode), all over the body tingling, numbness, uncomfortable, confusion, difficulty walking, shaking, insomnia and eyes could not see clearly.Information regarding any further hospitalization details, corrective treatments and outcome of the remaining events was not provided.Insulin lispro protamine suspension 75%/insulin lispro 25% treatment was continued.It was unknown if he would re-start insulin lispro protamine suspension 50%/insulin lispro 50% treatment or not.The operator of the device and his/her training status was not reported.The general humapen ergo ii model duration of use was not provided and the suspect humapen ergo ii duration of use was around six months as it was started in (b)(6)2019.The action taken with the suspect humapen ergo ii was not provided and the suspect humapen ergo ii device associated with product complaint (b)(4) was not returned to the manufacturer.The reporting consumers did not provide a relatedness assessment between the events and insulin lispro protamine suspension 75%/insulin lispro 25%, insulin lispro protamine suspension 50%/insulin lispro 50% treatments or humapen ergo ii device.Update 07-jun-2019: this case was determined to be non-valid since there was no identifiable valid adverse event reported.Update 17-jun-2019: the case was downgraded to non-serious and became valid after additional information was received on 11-jun-2019 from second reporter via psp.Added a new reporter, all medical histories, three concomitant medications and weight, height of patient.Added a suspect medication humalog 25 and suspect device.Deleted the suspect humalog 50 and added in historical medication.Deleted the serious event of hospitalization and added a non-serious event of injection site pain.Updated the narrative with new information.Update 21-jun-2019: additional information was received on 11-jun-2019 from rcp regarding pc number (b)(4).The action item to monitor pc was set accordingly.No new medically significant information was received and no changes were done to the case.Update 12-jul-2019: additional information was received from the initial reporter via the psp on 10-jul-2019.This case was upgraded to serious (p1) due to addition of serious event of fasting blood glucose increased due to hospitalization and associated with reusable device humapen ergo ii.Added new suspect with insulin lispro protamine suspension 50%/insulin lispro 50% treatment with associated serious event of fasting blood glucose increased and deleted from historical medication and lab test with fasting blood glucose with values of more than 20.Updated eu/ca field of reusable device humapen ergo ii, causality statement and narrative with new information.Edit 18jul2019: updated medwatch fields for expedited device reporting.No new information added.Update 22jul2019: additional information received on 22jul2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information for the suspect humapen ergo ii device associated with product complaint (b)(4), which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.Update 14-jan -2020: additional information was received on 09-jan-2020 and 13-jan-2020 from initial reporter via psp were processed together.Added medical history of familial risk factor, laboratory data of blood glucose, dosage regimen for insulin lispro protamine suspension 75%/insulin lispro 25%, concomitant medication of acarbose, treatment drug, serious event of high blood sugar (second episode), non-serious events (tingling, numbness, uncomfortable, confusion, difficulty walking, shaking, insomnia and eyes could not see clearly).Updated the action taken for the insulin lispro protamine suspension 75%/insulin lispro 25% therapy.Updated the narrative with new information.
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