| Model Number MS9557 |
| Device Problems
Inaccurate Delivery (2339); Mechanics Altered (2984)
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| Patient Problem
Hyperglycemia (1905)
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| Event Date 12/31/2020 |
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Event Type
Injury
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Manufacturer Narrative
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Narrative field: new, updated, and corrected information is referenced within the update statements.Please refer to update statement(s) dated (b)(6) 2021.No further follow-up is planned.Evaluation summary: a male patient reported that his humapen ergo ii device was difficult to push, the injection speed was not very uniform during the process of pressing down the injection pen, sometimes quick and sometimes slow.When injecting the last dose unit, the injection button was particularly difficult to press down.So possibly, he might have not injected the insulin completely.The patient experienced abnormal blood glucose.The device was not returned to the manufacturer for investigation (batch 1608d02, manufactured august 2016).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review did not identify any atypical findings with regard to uneven injection force issues, and the batch threshold review did not identify any atypical findings with regard to dose accuracy issues.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.The patient stated he used the device four to five years.The core instructions for use state the humapen ergo ii has been designed to be used for up to 3 years after first use.There is evidence of improper use.The patient used the device beyond the recommended use period.It is unknown if the misuse is relevant to the complaint or the event of abnormal blood glucose.
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Event Description
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Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), with additional information from the initial reporter via psp, concerned a (b)(6) patient of unknown origin.Medical history included ear was not good, blurry vision, parkinson, prostatic infection, poor hearing, cephalosporin allergy, diabetes and colon cancer surgery in 2008.Concomitant medications included unspecified oral medication for parkinson's disease, insulin 30r (as reported), linagliptin, repaglinide for the mellitus and insulin all used for type ii treatment of diabetes mellitus.The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) injections (humalog mix25) via cartridge via a reusable humapen ergo ii, 16 units at unknown frequency, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date.He received insulin lispro protamine suspension 75%/ insulin lispro 25% therapy via a reusable humapen ergo ii approximately from (b)(6) 2016.He also received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog 50, 100u/ml) cartridge via unknown device, at bid (20-22 u morning, 18-20u night) subcutaneously for the treatment of type ii diabetes mellitus beginning on an unknown date in (b)(6) 2017.On an unknown date, he started taking 20 units in the morning and 20 units at night.On an unknown date, in (b)(6) 2017, while on insulin therapies, he had hands tremble and in (b)(6) 2018, he was diagnosed with parkinson.The event parkinson was considered serious by the company due to its medical significance reason.He was hospitalized in (b)(6) 2018 (reason unknown).On (b)(6) 2018, while on insulin lispro protamine suspension 50%/insulin lispro 50% therapy, he appeared fever, pneumonia condition and urinary tract infection.On an unknown date in (b)(6) 2018, he was hospitalized for fever, pneumonia and urinary tract infection.On an unknown date in (b)(6) 2018, he got discharged from the hospital.On an unknown date, his blood glucose condition was controlled not well (poor controlled), blood glucose was high when eating much, blood glucose was low when eating less, always be there, basically high, blood glucose value was 11 more than 12 (units not provided) with an empty belly, postprandial blood glucose was 14 more than 15 (units not provided).His blood sugar was unstable, major element was high blood sugar.The blood sugar value was tested lower by our company glucometer, was tested higher by other manufacturer glucometer.On an unknown date, his preexisting condition of ear was not good was more serious.The event of ear was not good was considered serious by the company due to its medical significance reason.On an unknown date, he got nephritis.On an unknown date in (b)(6) 2019, he was hospitalized due to nephritis and received unspecified infusion and unspecified injection.Further information regarding hospitalization was unknown.On an unknown date, after using insulin lispro protamine suspension 50%/insulin lispro 50% therapy, her eyes vision were more blurred.On an unknown date, he had the situation that it was strenuous to press down the last unit.For example, when the humapen ergo ii need to inject 16 dose units, the injection speed was not very uniform during the process of pressing down the injection pen, sometimes quick sometimes slow.When injecting the last dose unit, the injection button was particularly difficult to press down while using insulin lispro protamine suspension 75%/ insulin lispro 25% via humapen ergo ii (pc number: (b)(4); lot 1608d02).So possibly, he might have not injected insulin lispro protamine suspension 75%/ insulin lispro 25% dose completely.On (b)(6) 2020, he was hospitalized due to unstable blood glucose.Since an unknown date in 2020, he lost weight from 70 kg to 60 kg.On (b)(6) 2020, he had blood glucose on high side.Information regarding further corrective treatments was not reported.On an unspecified date, he experienced an urinary infection which was caused by parkinson's and due to the event in (b)(6) 2020 he was hospitalized for one month till (b)(6) 2020, it was reported that at discharge date, he was already recovered from the event.It was also reported that on an unknown date in (b)(6) 2020, he was hospitalized due to unstable blood glucose and urinary tract infection.On (b)(6) 2021, he was hospitalized because of the parkinson; it was reported that he could not walk suddenly and the whole body shivered severely, he had muscle spasm all over the body, the leg was painful and it could not move.As of (b)(6) 2021, he administered morning 16 units and night 14 units.As of (b)(6) 2021, he was taking 32 units (16 in morning and 16 at night) of insulin lispro protamine suspension 50%/ insulin lispro 50% therapy.On (b)(6) 2021, he was discharged from hospital.By (b)(6) 2021, his blood glucose was well controlled.Other information was unknown.Outcome for the events pneumonia and urinary tract infection was recovering while outcome of remaining events were unknown.She recovered from third episode of urinary tract infection, second episode of blood glucose increased and outcome of remaining events was not provided.Insulin lispro protamine suspension 50%/insulin lispro 50% therapy was ongoing while status of insulin lispro protamine suspension 75%/ insulin lispro 25% therapy was unknown.The patient was the operator of humapen ergo ii and his training status was not provided.The general humapen ergo model duration was approximately four years and six months (stated approximately from (b)(6) 2016) and suspect humapen ergo ii duration of use was not provided.The action taken with the suspect humapen ergo ii, manufactured in aug2016, was unknown and was not returned to the manufacturer.The reporting consumer did not provide an opinion of relatedness of the events of ear was not good, vision blurred, nephritis and second episode of urinary tract infection, third episode of urinary tract infection second episode of blood glucose increased , blood glucose abnormal and weight decreased with insulin lispro protamine suspension 50%/insulin lispro 50% therapy.The reporting consumer did not know about the relatedness assessment of the remaining events with insulin lispro protamine suspension 50%/insulin lispro 50% therapy.The reporting consumer did not provide an opinion of relatedness between the events and insulin lispro protamine suspension 75%/ insulin lispro 25%.The reporting consumer related the event of incorrect dose administered with humapen ergo ii while did not provide an opinion of relatedness between the remaining events and humapen ergo ii.Update 01-oct-2018: additional information was received on (b)(6) 2018 from the initial reporter via the psp.Added two medical history of parkinson's and colon cancer surgery.Updated indication of the concomitant drugs and updated dosage regimen of repaglinide.Updated indication, dosage regimen and formulation of insulin lispro protamine suspension 50%/insulin lispro 50% suspect drug.Added one serious event of urinary tract infection.Updated outcome of the serious events of pneumonia.Updated as reported causality for all the previously captured events.Updated causality statement and narrative with new information.Update 28-aug-2019: additional information was received on 23-aug-2019 from the initial reporter via the psp.Added demographics of the patient, three medical history of ear was not good, poor hearing and cephalosporin allergy.Added new batch and dosage regimen of suspect lispro protamine suspension 50%/insulin lispro 50% therapy, and two serious events of ear disorder and nephritis.Updated causality statement and narrative with new information.Update 03-sep-2019: additional information was received on 28-aug-2019 from the initial reporter via the psp.Added one medical history of vision blurred and one non-serious event of vision blurred.Updated causality statement and narrative with new information.Update 10-mar-2021: additional information was received on 08-mar-2021 from the initial consumer reporter via the psp.Added one additional suspect drug: humalog 25mix and one suspect humapen ergo ii.Added one non-serious event of incorrect dose administered.Updated causality statement and narrative with new information.Update 23-mar-2021: additional information was received on 12-mar-2021 from the initial consumer reporter via the psp.Added a serious event of parkinson's (possible worsening) and a new batch for suspect drug (humalog 50).Updated the medical history of parkinson's as ongoing, patient demographics, causality statement and narrative with new information.Update 26-mar-2021: additional information received on 22-mar-2021, from initial reporter.Added new dosage regimens with new lot number and new dosage for the insulin lispro protamine suspension 50%/ insulin lispro 50% suspect drug.Updated the narrative with new information regarding the hospitalization details.Update 12-apr-2021: additional information received on 01-apr-2021 from the initial reporter via psp.Added diabetes as medical history, discharge date for the event of parkinson's disease and second episode of serious event of urinary tract infection.Updated narrative with new information.Update 20-may-2021: additional information was received from initial reporter via psp, on 11-may-2021.Added two new dosage regimen for suspect drug insulin lispro 50, two new lab test, new serious events of blood glucose abnormal, urinary tract infection (third episode) and new non serious events of weight decreased and blood glucose increased (second episode).Updated causality statement and narrative with new information.Update 03jun2021: additional information received on 03jun2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information and device return status to not returned to manufacturer.Added date of manufacturer for pc 5501785 associated with lot 1608d02 of humapen ergo ii device.Upon internal review, updated chronological order.Corresponding fields and narrative updated accordingly.Edit 10jun2021: upon internal reviewthe follow up information received on 11may2021 was determined to have been medically significant for device; therefore the general tab was updated to reflect medically significant device follow up.
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Manufacturer Narrative
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B.5.Narrative field: new, updated, and corrected information is referenced within the update statements in b.5.Please refer to update statement(s) dated (b)(6) 2021 in the b.5.Field.No further follow-up is planned.Evaluation summary: a male patient reported that his humapen ergo ii device was difficult to push, the injection speed was not very uniform during the process of pressing down the injection pen, sometimes quick and sometimes slow.When injecting the last dose unit, the injection button was particularly difficult to press down.So possibly, he might have not injected the insulin completely.The patient experienced abnormal blood glucose.The investigation of the returned device (batch 1608d02, manufactured august 2016) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.The patient stated he used the device four to five years.The core instructions for use state the humapen ergo ii has been designed to be used for up to 3 years after first use.There is evidence of improper use.The patient used the device beyond the recommended use period this misuse may not be relevant to the complaint or the event of abnormal blood glucose, as the returned device met performance specifications.
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Event Description
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Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), with additional information from the initial reporter via psp, concerned a 74 year old male patient of unknown origin.Medical history included ear was not good, blurry vision, parkinson, prostatic infection, poor hearing, cephalosporin allergy, diabetes and colon cancer surgery in 2008.Concomitant medications included unspecified oral medication for parkinsons disease, insulin 30r (as reported), linagliptin, repaglinide for the mellitus and insulin all used for type ii treatment of diabetes mellitus.The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) injections (humalog mix25) via cartridge via a reusable humapen ergo ii, 16 units at unknown frequency, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date.He received insulin lispro protamine suspension 75%/ insulin lispro 25% therapy via a reusable humapen ergo ii approximately from (b)(6) 2016.(length of use assessed as longer than three years) he also received insulin lispro protamine suspension 50%/ insulin lispro 50% (rdna origin) injections (humalog 50, 100u/ml) cartridge via unknown device, at bid (20 to 22 u morning, 18t o 20u night) subcutaneously for the treatment of type ii diabetes mellitus beginning on an unknown date in (b)(6) 2017.On an unknown date, he started taking 20 units in the morning and 20 units at night.On an unknown date, in (b)(6) 2017, while on insulin therapies, he had hands tremble and in (b)(6) 2018, he was diagnosed with parkinson.The event parkinson was considered serious by the company due to its medical significance reason.He was hospitalized in (b)(6) 2018 (reason unknown).On (b)(6) 2018, while on insulin lispro protamine suspension 50%/ insulin lispro 50% therapy, he appeared fever, pneumonia condition and urinary tract infection.On an unknown date in (b)(6) 2018, he was hospitalized for fever, pneumonia and urinary tract infection.On an unknown date in (b)(6) 2018, he got discharged from the hospital.On an unknown date, his blood glucose condition was controlled not well (poor controlled), blood glucose was high when eating much, blood glucose was low when eating less, always be there, basically high, blood glucose value was 11 more than 12 (units not provided) with an empty belly, postprandial blood glucose was 14 more than 15 (units not provided).His blood sugar was unstable, major element was high blood sugar.The blood sugar value was tested lower by our company glucometer, was tested higher by other manufacturer glucometer.On an unknown date, his preexisting condition of ear was not good was more serious.The event of ear was not good was considered serious by the company due to its medical significance reason.On an unknown date, he got nephritis.On an unknown date in (b)(6) 2019, he was hospitalized due to nephritis and received unspecified infusion and unspecified injection.Further information regarding hospitalization was unknown.On an unknown date, after using insulin lispro protamine suspension 50%/insulin lispro 50% therapy, her eyes vision were more blurred.On an unknown date, he had the situation that it was strenuous to press down the last unit.For example, when the humapen ergo ii need to inject 16 dose units, the injection speed was not very uniform during the process of pressing down the injection pen, sometimes quick sometimes slow.When injecting the last dose unit, the injection button was particularly difficult to press down while using insulin lispro protamine suspension 75%/ insulin lispro 25% via humapen ergo ii (pc number: (b)(4); lot 1608d02).So possibly, he might have not injected insulin lispro protamine suspension 75%/ insulin lispro 25% dose completely.On (b)(6) 2020, he was hospitalized due to unstable blood glucose.Since an unknown date in 2020, he lost weight from 70 kg to 60 kg.On (b)(6) 2020, he had blood glucose on high side.Information regarding further corrective treatments was not reported.On an unspecified date, he experienced an urinary infection which was caused by parkinsons and due to the event in (b)(6) 2020 he was hospitalized for one month till (b)(6) 2020, it was reported that at discharge date, he was already recovered from the event.It was also reported that on an unknown date in (b)(6) 2020, he was hospitalized due to unstable blood glucose and urinary tract infection.On (b)(6) 2021, he was hospitalized because of the parkinson; it was reported that he could not walk suddenly and the whole body shivered severely, he had muscle spasm all over the body, the leg was painful and it could not move.As of (b)(6) 2021, he administered morning 16 units and night 14 units.As of (b)(6) 2021, he was taking 32 units (16 in morning and 16 at night) of insulin lispro protamine suspension 50%/ insulin lispro 50% therapy.On (b)(6) 2021, he was discharged from hospital.By (b)(6) 2021, his blood glucose was well controlled.Other information was unknown.Outcome for the events pneumonia and urinary tract infection was recovering while outcome of remaining events were unknown.He recovered from third episode of urinary tract infection, second episode of blood glucose increased and outcome of remaining events was not provided.Insulin lispro protamine suspension 50%/ insulin lispro 50% therapy was ongoing while status of insulin lispro protamine suspension 75%/ insulin lispro 25% therapy was unknown.The patient was the operator of humapen ergo ii and his training status was not provided.The general humapen ergo ii model duration was approximately four years and six months (stated approximately from (b)(6) 2016) and suspect humapen ergo ii duration of use was not provided.The action taken with the suspect humapen ergo ii, manufactured in (b)(6) 2016, was unknown.The suspect humapen ergo ii (lot 1608d02) associated with product complaint (b)(4) was returned to the manufacturer on (b)(6) 2021.The reporting consumer did not provide an opinion of relatedness of the events of ear was not good, vision blurred, nephritis and second episode of urinary tract infection, third episode of urinary tract infection second episode of blood glucose increased , blood glucose abnormal and weight decreased with insulin lispro protamine suspension 50%/ insulin lispro 50% therapy.The reporting consumer did not know about the relatedness assessment of the remaining events with insulin lispro protamine suspension 50%/ insulin lispro 50% therapy.The reporting consumer did not provide an opinion of relatedness between the events and insulin lispro protamine suspension 75%/ insulin lispro 25%.The reporting consumer related the event of incorrect dose administered with humapen ergo ii while did not provide an opinion of relatedness between the remaining events and humapen ergo ii.Update 01-oct-2018: additional information was received on 26-sep-2018 from the initial reporter via the psp.Added two medical history of parkinsons and colon cancer surgery.Updated indication of the concomitant drugs and updated dosage regimen of repaglinide.Updated indication, dosage regimen and formulation of insulin lispro protamine suspension 50%/ insulin lispro 50% suspect drug.Added one serious event of urinary tract infection.Updated outcome of the serious events of pneumonia.Updated as reported causality for all the previously captured events.Updated causality statement and narrative with new information.Update 28-aug-2019: additional information was received on 23-aug-2019 from the initial reporter via the psp.Added demographics of the patient, three medical history of ear was not good, poor hearing and cephalosporin allergy.Added new batch and dosage regimen of suspect lispro protamine suspension 50%/ insulin lispro 50% therapy, and two serious events of ear disorder and nephritis.Updated causality statement and narrative with new information.Update 03-sep-2019: additional information was received on 28-aug-2019 from the initial reporter via the psp.Added one medical history of vision blurred and one non-serious event of vision blurred.Updated causality statement and narrative with new information.Update 10-mar-2021: additional information was received on 08-mar-2021 from the initial consumer reporter via the psp.Added one additional suspect drug: humalog 25mix and one suspect humapen ergo ii.Added one non-serious event of incorrect dose administered.Updated causality statement and narrative with new information.Update 23-mar-2021: additional information was received on 12-mar-2021 from the initial consumer reporter via the psp.Added a serious event of parkinsons (possible worsening) and a new batch for suspect drug (humalog 50).Updated the medical history of parkinsons as ongoing, patient demographics, causality statement and narrative with new information.Update 26-mar-2021: additional information received on 22-mar-2021, from initial reporter.Added new dosage regimens with new lot number and new dosage for the insulin lispro protamine suspension 50%/ insulin lispro 50% suspect drug.Updated the narrative with new information regarding the hospitalization details.Update 12-apr-2021: additional information received on 01-apr-2021 from the initial reporter via psp.Added diabetes as medical history, discharge date for the event of parkinsons disease and second episode of serious event of urinary tract infection.Updated narrative with new information.Update 20-may-2021: additional information was received from initial reporter via psp, on 11-may-2021.Added two new dosage regimen for suspect drug insulin lispro 50, two new lab test, new serious events of blood glucose abnormal, urinary tract infection (third episode) and new non serious events of weight decreased and blood glucose increased (second episode).Updated causality statement and narrative with new information.Update 03jun2021: additional information received on 03jun2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information and device return status to not returned to manufacturer.Added date of manufacturer for pc 5501785 associated with lot 1608d02 of humapen ergo ii device.Upon internal review, updated chronological order.Corresponding fields and narrative updated accordingly.Edit 10jun2021: upon internal review the follow up information received on 11may2021 was determined to have been medically significant for device; therefore the general tab was updated to reflect medically significant device follow up.Update 07jul2021: additional information received on 02jul2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information and device return status to returned to manufacturer, and malfunction from unknown to no.Upon review updated case priority.Added returned date for the humapen ergo ii device (lot 1608d02) associated with product complaint (b)(4) which was returned to the manufacturer.Corresponding fields and narrative updated accordingly.
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Search Alerts/Recalls
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