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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO II; FOR TREATMENT PURPOSES
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ELI LILLY AND COMPANY HUMAPEN ERGO II; FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9557
Device Problems Degraded (1153); Peeled/Delaminated (1454); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inaccurate Delivery (2339)
Patient Problem Hypoglycemia (1912)
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
(b)(4).This solicited case, reported by a consumer via patient support program (psp), concerned a (b)(6)-year-old (at the time of initial report) han female patient.Medical history included hypertension.Concomitant medication included liraglutide and acarbose for type 2 diabetes mellitus, canagliflozin for nephropathy and abnormal kidney function, folic acid, sodium bicarbonate and pioglitazone for unknown indication.The patient received human insulin (rdna origin) injections (humulin, 100u/ml), from cartridge, via humapen ergo ii, 35 units in morning and night, subcutaneously, for the treatment of type 2 diabetes mellitus, beginning on an unknown date.The humapen ergo ii was used over 10 years ago.She also used insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin), injections (humalog mix 50, 100u/ml) from a cartridge, via humapen ergo ii, two times a day (35 international units each morning and evening), subcutaneously, for the treatment of type 2 diabetes mellitus, beginning on an unknown date (reported as over ten years ago as of (b)(6) 2019).On an unknown date, while on insulin lispro protamine suspension 50%/insulin lispro 50% and human insulin therapy, her height was before 160cm, and currently her height was only 157cm.On an unknown date, her blood glucose was abruptly high (units and reference range not provided) or low (units and reference range not provided).On an unknown date, when he went to see a doctor for diabetes in community hospital, the blood glucose was high so her doctor added pioglitazone.On an unknown date, her blood glucose value was low to 2.4 (units and reference range not provided), her postprandial blood glucose was only 3.1(units and reference range not provided).On an unknown date, she had low blood glucose (units and reference range not provided).On (b)(6) 2019 due to low blood glucose, she was hospitalized for around 20 days (approximately until (b)(6) 2019).On (b)(6) 2019 on advice by doctor, after hospitalization, she was changed from insulin lispro protamine suspension 50%/insulin lispro 50% to insulin glargine (manufacturer unknown), via subcutaneous route for type ii diabetes mellitus.The dose and frequency of insulin glargine was unknown.After using insulin glargine, the blood glucose was still high (units and reference range not provided), and then she was changed to insulin lispro protamine suspension 75%/insulin lispro 25% from cartridge via humapen ergo ii, 25 units in morning and night, via subcutaneous route, for type ii diabetes mellitus.After hospitalization, she was found out to have kidney disease, and her kidney function was incomplete.The doctor prescribed some medicine for kidney disease and kidney function incomplete.On an unknown date, the scale on the dose knob window was not obvious, the grey plastic area below the dose knob window was peeled off ((b)(4)/lot no 1102d02).After she used human insulin and insulin lispro protamine suspension 75%/insulin lispro 25%, she adjusted the dose by own self due to scale on dose window of the injection pen was not clear, causing the injection dose to be inaccurate.On an unknown date in 2019, human insulin was discontinued and its current status was unknown.Information regarding corrective treatment and events outcome was unknown.It was unknown if insulin lispro protamine suspension 50%/insulin lispro 50% and insulin glargine was re-started or not and therapy status of insulin lispro protamine suspension 75%/insulin lispro 25% was continued.The operator of the humapen ergo ii was patient and her training status was not provided.The general humapen ergo ii was started over 10 years ago (as of (b)(6) 2020) and the suspect humapen ergo ii duration of use was unknown.The action taken with humapen ergo ii and its return status was unknown.The initial reporting consumer did not provide the relatedness of events with insulin lispro protamine suspension 50%/insulin lispro 50%, human insulin, insulin glargine and insulin lispro protamine suspension 75%/insulin lispro 25% therapy.The initial reporting consumer considered the event of incorrect dose administered was related to the humapen ergo ii issue while did not provide the relatedness of remaining events with humapen ergo ii.Edit 09-oct-2019: upon review of the information received on 27-sep-2019, updated the coding from kidney disorder to renal disease for kidney disease and ranking of the events.No other changes were made to the case.Update 16-oct-2019: additional information was received from initial reporting consumer via psp on 12-oct-2019.Updated the action taken for human insulin to no change.Update the narrative with new information.Update 28-oct-2019: additional information was received from initial reporter via psp on 21-oct-2019.The case was upgraded to serious by the addition of serious event blood glucose decreased.Updated narrative with new information.Update 15-oct-2020: additional information was received from initial reporting consumer via a psp on 09-oct-2020.Added: suspect device of humapen ergo ii, one non-serious event of incorrect dose administered, approximate stop date of hospitalization, medical history of hypertension, dose and frequency of liraglutide, dose of humulin, dose, frequency, batch number and route of humaog 25, action taken of humalog 25 from unknown to no change and status ongoing, partial stop date of humulin.Updated: upgraded the non-serious event of blood glucose decreased to serious event with hospitalization reason, other manufacture device of humalog 50 from unknown to no, formulation of humulin and humalog 25 from unknown to cartridge, action taken of humulin from no change to unknown and accordingly its de challenge and re challenge.Upon review, added the causality statement in narrative, dose, frequency and route details of insulin glargine in narrative and start date of humalog 25.Narrative was updated with new information accordingly.Edit 19oct2020: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting and added contact log accordingly.No new information added.
 
Manufacturer Narrative
B.5.Narrative field: new, updated, and corrected information is referenced within the update statements in b.5.Please refer to update statement dated 03dec2020 in the b.5.Field.No further follow-up is planned.Evaluation summary: female patient reported scale on doseknob window of humapenergoii device wasnt obvious grey plastic area below doseknob window was peeled off.Reportedly"she adjusted dose by own self due to scale on dosewindow of injection pen was not clear,causing injection dose to be inaccurate."she experienced decreased bloodglucose.Investigation of returned device batch1102d02 manufactured february2011 found dose units were able to be seen in dosewindow and were legible.Device body was returned with tape on,investigation found pen housing was cracked,with evidence of excess force applied while in field,not related to manufacturing process.Due to damage,no further testing could be conducted.Malfunction confirmed.Visual defects due to field damage(not related to manufacturing process)that did not impact device functionality.Internal examination of device found all components normal.All humapenergoii devices are assessed for injection screw travel at end of manufacturing process,thus ensuring device functionality/ dose accuracy with high probability.Core instructions for use provide proper care/storage instructions.Patient continued to use device after experiencing alleged complaint issue.Core instructions for use state if any parts of your humapenergoii appear broken or damaged,do not use.While its unknown how long patient used device,based on amount of time elapsed since device was manufactured(february 2011),its likely patient used it beyond its approved use life.User manual states humapenergoii has been designed to be used for up to 3 years after first use.There is evidence of improper use.Patient continued to use device after experiencing alleged complaint issue,adjusting her dose when unable to see dosewindow clearly.This may be relevant to event of decreased bloodglucose.Cracked housing/other damage are consistent with damage while in field.Additionally patient likely used device beyond approved use life.Its unknown if misuses are relevant to event decreased bloodglucose.
 
Event Description
Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via patient support program (psp), concerned a 63-year-old (at the time of initial report) han female patient.Medical history included hypertension.Concomitant medication included liraglutide and acarbose for type 2 diabetes mellitus, canagliflozin for nephropathy and abnormal kidney function, folic acid, sodium bicarbonate and pioglitazone for unknown indication.The patient received human insulin (rdna origin) injections (humulin, 100u/ml), from cartridge, via humapen ergo ii, 35 units in morning and night, subcutaneously, for the treatment of type 2 diabetes mellitus, beginning on an unknown date.The humapen ergo ii was used over 10 years ago.She also used insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin), injections (humalog mix 50, 100u/ml) from a cartridge, via humapen ergo ii, two times a day (35 international units each morning and evening), subcutaneously, for the treatment of type 2 diabetes mellitus, beginning on an unknown date (reported as over ten years ago as of (b)(6) 2019.On an unknown date, while on insulin lispro protamine suspension 50%/insulin lispro 50% and human insulin therapy, her height was before 160cm, and currently her height was only 157cm.On an unknown date, her blood glucose was abruptly high (units and reference range not provided) or low (units and reference range not provided).On an unknown date, when he went to see a doctor for diabetes in community hospital, the blood glucose was high so her doctor added pioglitazone.On an unknown date, her blood glucose value was low to 2.4 (units and reference range not provided), her postprandial blood glucose was only 3.1(units and reference range not provided).On an unknown date, she had low blood glucose (units and reference range not provided).On (b)(6) 2019 due to low blood glucose, she was hospitalized for around 20 days (approximately until 13-sep-2019).On 25-aug-2019 on advice by doctor, after hospitalization, she was changed from insulin lispro protamine suspension 50%/insulin lispro 50% to insulin glargine (manufacturer unknown), via subcutaneous route for type ii diabetes mellitus.The dose and frequency of insulin glargine was unknown.After using insulin glargine, the blood glucose was still high (units and reference range not provided), and then she was changed to insulin lispro protamine suspension 75%/insulin lispro 25% from cartridge via humapen ergo ii, 25 units in morning and night, via subcutaneous route, for type ii diabetes mellitus.After hospitalization, she was found out to have kidney disease, and her kidney function was incomplete.The doctor prescribed some medicine for kidney disease and kidney function incomplete.On an unknown date, the scale on the dose knob window was not obvious, the grey plastic area below the dose knob window was peeled off (pc no 5323988 /lot no 1102d02).After she used human insulin and insulin lispro protamine suspension 75%/insulin lispro 25%, she adjusted the dose by own self due to sacle on dose window of the injection pen was not clear, causing the injection dose to be inaccurate.On an unknown date in 2019, human insulin was discontinued and its current status was unknown.Information regarding corrective treatment and events outcome was unknown.It was unknown if insulin lispro protamine suspension 50%/insulin lispro 50% and insulin glargine was re-started or not and therapy status of insulin lispro protamine suspension 75%/insulin lispro 25% was continued.The operator of the humapen ergo ii was patient and her training status was not provided.The general humapen ergo ii was started over 10 years ago (as of 09-oct-2020) and the suspect humapen ergo ii duration of use was unknown.The suspect humapen ergo ii device (manufactured feb2011) associated with product complaint (b)(4) was returned to the manufacturer on 14oct2020.The initial reporting consumer did not provide the relatedness of events with insulin lispro protamine suspension 50%/insulin lispro 50%, human insulin, insulin glargine and insulin lispro protamine suspension 75%/insulin lispro 25% therapy.The initial reporting consumer considered the event of incorrect dose administered was related to the the humapen ergo ii issue while did not provide the relatedness of remaining events with humapen ergo ii.Edit 09-oct-2019: upon review of the information received on (b)(4) 2019, updated the coding from kidney disorder to renal disease for kidney disease and ranking of the events.No other changes were made to the case.Update 16-oct-2019: additional information was received from initial reporting consumer via psp on 12-oct-2019.Updated the action taken for human insulin to no change.Update the narrative with new information.Update 28-oct-2019: additional information was received from initial reporter via psp on 21-oct-2019.The case was upgraded to serious by the addition of serious event blood glucose decreased.Updated narrative with new information.Update 15-oct-2020: additional information was received from initial reporting consumer via a psp on 09-oct-2020.Added: suspect device of humapen ergo ii, one non-serious event of incorrect dose administered, approximate stop date of hospitalization, medical history of hypertension, dose and frequency of liraglutide, dose of humulin, dose, frequency, batch number and route of humaog 25, action taken of humalog 25 from unknown to no change and status ongoing, partial stop date of humulin.Updated: upgraded the non-serious event of blood glucose decreased to serious event with hospitalization reason, other manufacture device of humalog 50 from unknown to no, formulation of humulin and humalog 25 from unknown to cartridge, action taken of humulin from no change to unknown and accordingly its de challenge and re challenge.Upon review, added the causality statement in narrative, dose, frequency and route details of insulin glargine in narrative and start date of humalog 25.Narrative was updated with new information accordingly.Edit 19oct2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting and added contact log accordingly.No new information added.Update 03dec2020: additional information received on 02dec2020 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information, the european and canadian (eu/ca) device information, malfunction from unknown to yes/not cirm, and device return status to returned to manufacturer.Added date of manufacturer and date returned to manufacturer for the humapen ergo ii device associated with product complaint (b)(4).Corresponding fields and narrative updated accordingly.
 
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Brand Name
HUMAPEN ERGO II
Type of Device
FOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
MDR Report Key10748789
MDR Text Key213478444
Report Number1819470-2020-00146
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K151686
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 12/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMS9557
Device Lot Number1102D02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2020
Date Manufacturer Received12/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age63 YR
Patient Weight74
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