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| Model Number UNKNOWN |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Pain (1994); Numbness (2415)
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Event Type
Injury
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Manufacturer Narrative
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If device is returned, evaluation will be performed to determine if a malfunction has occurred.This is an initial report.A follow-up report will be submitted when the final evaluation is completed.
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Event Description
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(b)(4).This solicited case, reported by a consumer via patient support program (psp), concerned a (b)(6) female patient.Medical history included heart disease, cerebral infarction, cerebral thrombosis, hypertension, family allergic history to penicillin (from her father), the heart was not good, heart failure, eyes blurred, allergies, heart uncomfortable, foot had uncomfortable and her sister had diabetes, she received some unspecified antihypertensive drugs and had allergy, redness of face and uncomfortable and hospitalization due to an unknown reason in (b)(6) 2015.Previous drug adverse reaction and family drug reaction was none.Concomitant medications included repaglinide, for the treatment of diabetes mellitus type two, metformin and glucobay, for the treatment of type 2 diabetes mellitus (when ate too much felt uncomfortable), losartan potassium and hydrochlorothiazide, for the treatment of high blood pressure.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog mix50 100 u/ml) via cartridge, 30 units in the morning and 30 units at night; twice a daily (dose also reported as 10 units in the morning and 20 units at night), subcutaneously, for the treatment of type two diabetes mellitus, beginning in (b)(6) 2015 (conflicting information; therapy start date also reported as (b)(6) 2016), using humapen ergo ii (reusable device) since an unspecified date, on an unspecified date, as per the guidance of her treating physician, the dose of insulin lispro protamine suspension 50%/insulin lispro 50% therapy was adjusted to 20 units in the morning and 20 units in the night.Since being in insulin lispro protamine suspension 50%/insulin lispro 50% treatment, her blood glucose was not controlled well (no units, values and reference ranges were provided).On an unspecified date in (b)(6) 2017, she was hospitalized to regulate her high blood pressure (no units, values and reference ranges were provided).On an unspecified date, after hospitalization her high blood pressure was recovering.On an unspecified date, she was discharged from the hospital (no further information was provided).On an unspecified date in 2017, she experienced numbness, pain in the toes and pain in the feet and right leg.On an unspecified date in (b)(6) 2017, she hospitalized for treatment.On an unspecified date, she did computerised tomogram (ct) examination and she was diagnosed of fracture of the right leg meniscus and toes (no further information was provided).She felt foot pain was related to the foot neuropathy caused by poor blood glucose control (no units, values and reference ranges were provided).The feet meniscus and toes fractures were relevant to the falling down in 2012 or 2013 (preexisting condition).On (b)(6) 2017, she was hospitalized due to her blood glucose was not controlled well (no units, values and reference ranges were provided) in order to receive an unspecified treatment.On (b)(6) 2017, she felt her blood glucose was controlled and was discharged from the hospital on that same date (her fasting blood glucose value was 7.5 no units and her postprandial blood glucose value was 11.5 no units).On unknown date her weight decreased from (b)(6) (no units and reference ranges were provided).Since an unspecified date, she received old beijing ointment (as reported) as a corrective treatment of the pain in the legs.On an unspecified date, she experienced high blood sugar and her fasting blood sugar was as high as 18 point (no further information was provided).On (b)(6) 2017, she was hospitalized due to high blood sugar and her fasting blood sugar was as high as 18 point (no units, values and reference ranges were provided).After being improved her high blood sugar, she was discharged from the hospital on (b)(6) 2017.She thought her blood glucose was high because her diet was not well controlled and it was caused by eating the gui ge hong ointment (as reported).It was reported; the sugar content was relatively high and could regulate the viscera.On an unspecified date in (b)(6) 2017, while on insulin lispro protamine suspension 50%/insulin lispro 50% therapy, every time to eat more every time would occur the symptoms of high blood sugar, whole body uncomfortable and eyes blurred and then after taking her metformin and glucobay she had some improvement.On an unspecified date, during the use of insulin lispro protamine suspension 50%/insulin lispro 50% therapy, she had broken down of two humapen ergo ii (insulin pen) ((b)(4); batch number-unknown).As of (b)(6) 2018, her brain was so poor.It was reported that, she could not remember the name of insulin and she did not know whether associated with infarction (preexisting condition).As of (b)(6) 2018, the event of numbness and pain in the toes had been much better.The information regarding additional corrective treatment was not provided.The outcome of the events diabetes mellitus inadequate control, hypertension, blood glucose increased (serious event) and weight decreased were recovering while the outcome of the remaining events were not provided.Insulin lispro protamine suspension 50%/insulin lispro 50% treatment was continued.The operator of the humapen ergo ii was unknown and his/her training status was not provided.The humapen ergo ii model and suspect humapen ergo ii duration of use were not provided.The action taken with suspect humapen ergo ii was not provided and its returned was expected.The reporting consumer did not provide any opinion of relatedness between the events and insulin lispro protamine suspension 50%/insulin lispro 50% treatment or humapen ergo ii.The reporting consumer felt foot pain was related to the foot neuropathy caused by poor blood glucose control.The feet meniscus and toes fractures were relevant to the falling down in 2012 or 2013 (preexisting condition).The reporting consumer thought blood glucose was high because diet was not well controlled and it was caused by eating the gui ge hong ointment (the sugar content was relatively high and could regulate the viscera).Update 11-jan-2018: additional information was received on 09-jan-2018, from the initial consumer reporter via psp.The information received on 09-jan-2018 and 16-jan-2018 was processed together.Added: four serious events of hypertension, lower limb fracture, foot fracture and blood glucose increased; five non-serious events of blood glucose abnormal, neuropathy peripheral, general physical health deterioration, cerebral disorder and infarction; cerebral infarction, heart disorder, cardiac failure, vision blurred, hypersensitivity, limb discomfort, familial risk factor and falling down as a medical history; drug hypersensitivity, erythema and discomfort as historical adverse reaction; new dosage regimen of metformin; another indication for use of metformin; acarbose, losartan potassium and hydrochlorothiazide as concomitant medication; four dosage regimen of insulin lispro protamine suspension 50%/insulin lispro 50%; lab tests of ct and high blood pressure.Updated: the onset date of the event diabetes mellitus inadequate control; he weight of the patient; therapy start date of insulin lispro protamine suspension 50%/insulin lispro 50%; the event verbatim of the events weight decreased and diabetes mellitus inadequate control.Changed: the action taken of insulin lispro protamine suspension 50%/insulin lispro 50% to dose decreased from no change.Upon review of information received on 17-jul-2017 changed the reported as diagnosis as yes from no.Accordingly, the narrative was updated with new information.Update 19jan2018: updated medwatch fields for expedited device reporting.No new information added.
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Manufacturer Narrative
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If device is returned, evaluation will be performed to determine if a malfunction has occurred.Narrative field: new, updated and corrected information is referenced within the update statements.Please refer to update statement dated (b)(6) 2018 in the describe event or problem field.No further follow-up is planned.This report is associated with 1819470-2018-00024 since there is more than one device implicated.Evaluation summary: a female patient reported that her humapen ergo device had "broken down." the patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.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.There is no evidence of improper use or storage.
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Event Description
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(b)(4).This solicited case, reported by a consumer via patient support program (psp), concerned a (b)(6) asian female patient.Medical history included heart disease, cerebral infarction, cerebral thrombosis, hypertension, family allergic history to penicillin (from her father), the heart was not good, heart failure, eyes blurred, allergies, heart uncomfortable, foot had uncomfortable, falling down, and her sister had diabetes, she received some unspecified antihypertensive drugs and had allergy, redness of face and uncomfortable and hospitalization due to an unknown reason in (b)(6) 2015.Previous drug adverse reaction and family drug reaction was none.Concomitant medications included repaglinide, for the treatment of diabetes mellitus type two, metformin and glucobay, for the treatment of type 2 diabetes mellitus (when ate too much felt uncomfortable), losartan potassium and hydrochlorothiazide, for the treatment of high blood pressure.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog mix50 100 u/ml) via cartridge, 30 units in the morning and 30 units at night; twice a daily (dose also reported as10 units in the morning and 20 units at night), subcutaneously, for the treatment of type two diabetes mellitus, beginning in (b)(6) 2015 (conflicting information; therapy start date also reported as (b)(6) 2016), using a humapen ergo ii (reusable device) since an unspecified date.On an unspecified date, as per the guidance of her treating physician, the dose of insulin lispro protamine suspension 50%/insulin lispro 50% therapy was adjusted to 20 units in the morning and 20 units in the night.Since being in insulin lispro protamine suspension 50%/insulin lispro 50% treatment, her blood glucose was not controlled well (no units, values and reference ranges were provided).On an unspecified date in (b)(6) 2017, she was hospitalized to regulate her high blood pressure (no units, values and reference ranges were provided).On an unspecified date, after hospitalization her high blood pressure was recovering.On an unspecified date, she was discharged from the hospital (no further information was provided).On an unspecified date in 2017, she experienced numbness, pain in the toes and pain in the feet and right leg.On an unspecified date in (b)(6) 2017, she hospitalized for treatment.On an unspecified date, she did computerized tomogram (ct) examination and she was diagnosed of fracture of the right leg meniscus and toes (no further information was provided).She felt foot pain was related to the foot neuropathy caused by poor blood glucose control (no units, values and reference ranges were provided).The feet meniscus and toes fractures were relevant to the medical history of falling down (2012 or 2013 preexisting condition).On (b)(6) 2017, she was hospitalized due to her blood glucose was not controlled well (no units, values and reference ranges were provided) in order to receive an unspecified treatment.On (b)(6) 2017, she felt her blood glucose was controlled and was discharged from the hospital on that same date (her fasting blood glucose value was 7.5 no units and her postprandial blood glucose value was 11.5 no units).On unknown date her weight decreased from 90 kg to 82.5 kg (no units and reference ranges were provided).Since an unspecified date, she received old beijing ointment (as reported) as a corrective treatment of the pain in the legs.On an unspecified date, she experienced high blood sugar and her fasting blood sugar was as high as 18 point (no further information was provided).On (b)(6) 2017, she hospitalized due to high blood sugar and her fasting blood sugar was as high as 18 point (no units, values and reference ranges were provided).After being improved her high blood sugar, she was discharged from the hospital on (b)(6) 2017.She thought her blood glucose was high because her diet was not well controlled and it was caused by eating the gui ge hong ointment (as reported).It was reported; the sugar content was relatively high and could regulate the viscera.On an unspecified date in (b)(6) 2017, while on insulin lispro protamine suspension 50%/insulin lispro 50% therapy, every time to eat more every time would occur the symptoms of high blood sugar, whole body uncomfortable and eyes blurred and then after taking her metformin and glucobay she had some improvement.On an unspecified date, during the use of insulin lispro protamine suspension 50%/insulin lispro 50% therapy, she had broken down of two humapen ergo ii (insulin pen) ((b)(4)/lot number unknown; (b)(4)/lot number unknown).As of (b)(6) 2018, her brain was so poor.It was reported that, she could not remember the name of insulin and she did not know whether associated with infarction (preexisting condition).As of 09-jan-2018, the event of numbness and pain in the toes had been much better.The information regarding additional corrective treatment was not provided.The outcome of the events diabetes mellitus inadequate control, hypertension, blood glucose increased (serious event) and weight decreased were recovering while the outcome of the remaining events were not provided.Insulin lispro protamine suspension 50%/insulin lispro 50% treatment was continued.The operator of the humapen ergo ii devices was unknown and his/her training status was not provided.The humapen ergo ii models and suspect humapen ergo ii devices duration of use were not provided.The suspect humapen ergo ii devices associated with (b)(4) were not returned to the manufacturer.The reporting consumer did not provide any opinion of relatedness between the events and insulin lispro protamine suspension 50%/insulin lispro 50% treatment or humapen ergo ii.The reporting consumer felt foot pain was related to the foot neuropathy caused by poor blood glucose control.The feet meniscus and toes fractures were relevant to the falling down in 2012 or 2013 (preexisting condition).The reporting consumer thought blood glucose was high because diet was not well controlled and it was caused by eating the gui ge hong ointment (the sugar content was relatively high and could regulate the viscera).Update 11-jan-2018: additional information was received on 09-jan-2018, from the initial consumer reporter via psp.The information received on 09-jan-2018 and 16-jan-2018 was processed together.Added: four serious events of hypertension, lower limb fracture, foot fracture and blood glucose increased; five non-serious events of blood glucose abnormal, neuropathy peripheral, general physical health deterioration, cerebral disorder and infarction; cerebral infarction, heart disorder, cardiac failure, vision blurred, hypersensitivity, limb discomfort, familial risk factor and falling down as a medical history; drug hypersensitivity, erythema and discomfort as historical adverse reaction; new dosage regimen of metformin; another indication for use of metformin; acarbose, losartan potassium and hydrochlorothiazide as concomitant medication; four dosage regimen of insulin lispro protamine suspension 50%/insulin lispro 50%; lab tests of ct and high blood pressure.Updated: the onset date of the event diabetes mellitus inadequate control; he weight of the patient; therapy start date of insulin lispro protamine suspension 50%/insulin lispro 50%; the event verbatim of the events weight decreased and diabetes mellitus inadequate control.Changed: the action taken of insulin lispro protamine suspension 50%/insulin lispro 50% to dose decreased from no change.Upon review of information received on 17-jul-2017 changed the reported as diagnosis as yes from no.Accordingly, the narrative was updated with new information.Update 19jan2018: updated medwatch fields for expedited device reporting.No new information added.Update 13-feb-2018: added new concomitant device in order to process the product complaint accordingly.Update 15feb2018: additional information received on 15feb2018 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch/european and (b)(6) (eu/(b)(6)) device information, and device return status to not returned to manufacturer for (b)(4) associated with unknown lot of humapen ergo ii device.Upon internal review, updated concomitant device with (b)(4) to suspect device and reprocessed pc accordingly, and updated case priority.Corresponding fields and narrative updated accordingly.Update 19feb2018: additional information received on 19feb2018 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch/european and (b)(6) (eu/(b)(6)) device information.Noted the suspect humapen ergo ii device associated with (b)(4) was not returned to manufacturer.Corresponding fields and narrative updated accordingly.Upon review, updated operator of the device associated with (b)(4) from lay user/patient to other/unknown.Edit 27feb2018: updated medwatch fields for expedited device reporting; multiple devices.No new information added.
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Event Description
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Lilly case id: (b)(4).This solicited case, reported by a consumer via patient support program (psp), concerned a 63-years-old asian female patient.Medical history included heart disease, cerebral infarction, cerebral thrombosis, hypertension, family allergic history to penicillin (from her father), the heart was not good, heart failure, eyes blurred, allergies, heart uncomfortable, foot had uncomfortable, falling down, and her sister had diabetes, she received some unspecified antihypertensive drugs and had allergy, redness of face and uncomfortable and hospitalization due to an unknown reason in jan-2015.Previous drug adverse reaction and family drug reaction was none.Concomitant medications included repaglinide, for the treatment of diabetes mellitus type two, metformin and glucobay, for the treatment of type 2 diabetes mellitus (when ate too much felt uncomfortable), losartan potassium and hydrochlorothiazide, for the treatment of high blood pressure.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog mix50 100 u/ml) via cartridge, 30 units in the morning and 30 units at night; twice a daily (dose also reported as10 units in the morning and 20 units at night), subcutaneously, for the treatment of type two diabetes mellitus, beginning in jan 2015 (conflicting information; therapy start date also reported as apr-2016), using a humapen unspecified lilly pen (reusable device) since an unspecified date.On an unspecified date, as per the guidance of her treating physician, the dose of insulin lispro protamine suspension 50%/insulin lispro 50% therapy was adjusted to 20 units in the morning and 20 units in the night.Since being in insulin lispro protamine suspension 50%/insulin lispro 50% treatment, her blood glucose was not controlled well (no units, values and reference ranges were provided).On an unspecified date in mar-2017, she was hospitalized to regulate her high blood pressure (no units, values and reference ranges were provided).On an unspecified date, after hospitalization her high blood pressure was recovering.On an unspecified date, she was discharged from the hospital (no further information was provided).On an unspecified date in 2017, she experienced numbness, pain in the toes and pain in the feet and right leg.On an unspecified date in jun-2017, she hospitalized for treatment.On an unspecified date, she did computerized tomogram (ct) examination and she was diagnosed of fracture of the right leg meniscus and toes (no further information was provided).She felt foot pain was related to the foot neuropathy caused by poor blood glucose control (no units, values and reference ranges were provided).The feet meniscus and toes fractures were relevant to the medical history of falling down (2012 or 2013 preexisting condition).On (b)(6) 2017, she was hospitalized due to her blood glucose was not controlled well (no units, values and reference ranges were provided) in order to receive an unspecified treatment.On (b)(6)2017, she felt her blood glucose was controlled and was discharged from the hospital on that same date (her fasting blood glucose value was 7.5 no units and her postprandial blood glucose value was 11.5 no units).On unknown date her weight decreased from 90 kg to 82.5 kg (no units and reference ranges were provided).Since an unspecified date, she received old beijing ointment (as reported) as a corrective treatment of the pain in the legs.On an unspecified date, she experienced high blood sugar and her fasting blood sugar was as high as 18 point (no further information was provided).On (b)(6) 2017, she hospitalized due to high blood sugar and her fasting blood sugar was as high as 18 point (no units, values and reference ranges were provided).After being improved her high blood sugar, she was discharged from the hospital on (b)(6) 2017.She thought her blood glucose was high because her diet was not well controlled and it was caused by eating the gui ge hong ointment (as reported).It was reported; the sugar content was relatively high and could regulate the viscera.On an unspecified date in aug-2017, while on insulin lispro protamine suspension 50%/insulin lispro 50% therapy, every time to eat more every time would occur the symptoms of high blood sugar, whole body uncomfortable and eyes blurred and then after taking her metformin and glucobay she had some improvement.On an unspecified date, during the use of insulin lispro protamine suspension 50%/insulin lispro 50% therapy, she had broken down of two humapen devices (insulin pen) (product complaint: (b)(4)/lot number unknown; product complaint: (b)(4)/lot number unknown).As of on (b)(6) 2018, her brain was so poor.It was reported that, she could not remember the name of insulin and she did not know whether associated with infarction (preexisting condition).As of on (b)(6)2018, the event of numbness and pain in the toes had been much better.The information regarding additional corrective treatment was not provided.The outcome of the events diabetes mellitus inadequate control, hypertension, blood glucose increased (serious event) and weight decreased were recovering while the outcome of the remaining events were not provided.Insulin lispro protamine suspension 50%/insulin lispro 50% treatment was continued.The operator of the humapen devices was unknown and his/her training status was not provided.The humapen models and suspect humapen devices duration of use were not provided.The suspect humapen devices associated with product complaints: (b)(4) were not returned to the manufacturer.The reporting consumer did not provide any opinion of relatedness between the events and insulin lispro protamine suspension 50%/insulin lispro 50% treatment or humapen.The reporting consumer felt foot pain was related to the foot neuropathy caused by poor blood glucose control.The feet meniscus and toes fractures were relevant to the falling down in 2012 or 2013 (preexisting condition).The reporting consumer thought blood glucose was high because diet was not well controlled and it was caused by eating the gui ge hong ointment (the sugar content was relatively high and could regulate the viscera).Update 11-jan-2018: additional information was received on (b)(6) 2018, from the initial consumer reporter via psp.The information received on (b)(6) 2018 was processed together.Added: four serious events of hypertension, lower limb fracture, foot fracture and blood glucose increased; five non-serious events of blood glucose abnormal, neuropathy peripheral, general physical health deterioration, cerebral disorder and infarction; cerebral infarction, heart disorder, cardiac failure, vision blurred, hypersensitivity, limb discomfort, familial risk factor and falling down as a medical history; drug hypersensitivity, erythema and discomfort as historical adverse reaction; new dosage regimen of metformin; another indication for use of metformin; acarbose, losartan potassium and hydrochlorothiazide as concomitant medication; four dosage regimen of insulin lispro protamine suspension 50%/insulin lispro 50%; lab tests of ct and high blood pressure.Updated: the onset date of the event diabetes mellitus inadequate control; he weight of the patient; therapy start date of insulin lispro protamine suspension 50%/insulin lispro 50%; the event verbatim of the events weight decreased and diabetes mellitus inadequate control.Changed: the action taken of insulin lispro protamine suspension 50%/insulin lispro 50% to dose decreased from no change.Upon review of information received on 17-jul-2017 changed the reported as diagnosis as yes from no.Accordingly, the narrative was updated with new information.Update 19jan2018: updated medwatch fields for expedited device reporting.No new information added.Update 13-feb-2018: added new concomitant device in order to process the product complaint accordingly.Update 15feb2018: additional information received on 15feb2018 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch/european and canadian (eu/ca) device information, and device return status to not returned to manufacturer for (b)(4) associated with unknown lot of humapen device.Upon internal review, updated concomitant device with (b)(4) to suspect device and reprocessed pc accordingly, and updated case priority.Corresponding fields and narrative updated accordingly.Update 19feb2018: additional information received on 19feb2018 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch/european and canadian (eu/ca) device information.Noted the suspect humapen device associated with product complaint: (b)(4) was not returned to manufacturer.Corresponding fields and narrative updated accordingly.Upon review, updated operator of the device associated with product complaint: (b)(4) from lay user/patient to other/unknown.Edit 27feb2018: updated medwatch fields for expedited device reporting; multiple devices.No new information added.Edit 14-mar-2018: upon internal review, it was determined that devices coded as humapen ergo ii should be humapen unknown.Two devices and narrative were updated accordingly.Update 15mar2018: additional information received on 12mar2018 from the global product complaint database.Updated the dsss for both suspect devices and the eu/ca fields.Corresponding fields and narrative updated accordingly.Edit 15mar2018: unlocked case to add medically significant device follow up date of 12mar2018 as was omitted in error from previous case udpate.No new information was added.
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Manufacturer Narrative
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If device is returned, evaluation will be performed to determine if a malfunction has occurred.Event: narrative field: new, updated and corrected information is referenced within the update statements in event.Please refer to update statement dated 12mar2018 in the event field.No further follow-up is planned.This report is associated with 1819470-2018-00024 since there is more than one device implicated.Evaluaiton summary: a female patient reported that her humapen device (unspecified type) had "broken down." the patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.There is no evidence of improper use or storage.
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Search Alerts/Recalls
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