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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 Mechanical Problem (1384); Device Slipped (1584); Audible Prompt/Feedback Problem (4020)
Patient Problem Hyperglycemia (1905)
Event Date 01/31/2017
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.This report is associated with 1819470-2020-00126 since there is more than one device implicated.
 
Event Description
Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse event and product complaints (pcs), with additional information from the initial reporter, concerned a (b)(6) years-old male patient of unknown origin.Medical history included father got diabetes.Previous drug adverse reaction and family drug reaction were none.Concomitant medication included metformin for diabetes.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100u/ml) from cartridge formulation, subcutaneously at twice daily (28 units in morning, 24 units in night) from 2000 or 2010 or 2011 (10-20 years ago).On an unknown date in 2010 he started taking human insulin isophane suspension 70%/human insulin 30% via reusable device (humapen ergo ii; tone blue).On an unknown date in 2010 he was hospitalized (specific reason was not provided).In the beginning, when pressed the humapen ergo ii it was going down unit by unit and it would slide down a lot all at once when near to the end of the injection.There was no clicking sound when the injection pen was pressed (pc (b)(4), unknown lot number).He used the first humapen ergo ii device till (b)(6) or (b)(6) 2017 (improper use of the device).On an unknown date in (b)(6) or (b)(6) 2017, he got the replacement of the first humapen ergo ii (tone blue) and started it in (b)(6) or (b)(6) 2017.On an unknown date in 2017, he was hospitalized for treatment again because the blood glucose was increased on an unknown date in about 2017.He stopped taking human insulin isophane suspension 70%/human insulin 30% by medical advice and changed to insulin lispro 50%/ insulin lispro protamine suspension 50% (humalog 50).As of (b)(6) 2018, on an unknown date his blood glucose was fine and he was discharged from hospital.In the beginning when pressed the humapen ergo ii device it was going down unit by unit and it would slide down a lot all at once when near to the end of the injection in around (b)(6) 2020.There was no clicking sound when the injection pen was pressed (pc (b)(4), lot 1504d02).Information regarding further corrective treatment was not provided.He was recovering from the event.It was unknown if the human insulin isophane suspension 70%/human insulin 30% therapy would be restarted.The patient was the operator of the humapen ergo ii devices and his training status was not provided.The general humapen ergo ii model duration of use was about 10 years as the first humapen ergo ii was started sometime in 2010.The first suspect humapen ergo ii duration of use was approximately seven years as it was started somewhere in 2010 (improper use of the device).The second suspect humapen ergo ii (lot 1504d02) duration of use was approximately 3 years as it was started in (b)(6) 2017.The first suspect humapen ergo was replaced for the second suspect humapen ergo ii (lot 1504d02).The second suspect humapen ergo ii was returned on 16sep2020.The initial reporting consumer did not know if the event of blood glucose increased was related to insulin human insulin isophane suspension 70%/human insulin 30% drug but thought the blood glucose increased was related to diet, and did not provide relatedness assessment between the event and humapen ergo ii devices.Update 17-sep-2020: additional information received on 14sep2020 and on 16sep2020 were processed at the same time.The information was provided from the initial reporter.Added event onset date for the event of blood glucose increased.Updated as reported causality for the event of blood glucose increased from no to unknown.Added two suspect device as humapen ergo ii.Updated insulin human mix 70 coding with cartridge formulation.Added one lab test.Added indication of insulin human insulin isophane suspension 70%/human insulin 30%.Updated causality statement and narrative with new information.Narrative was updated accordingly.Edit 22sep2020: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting and added contact log accordingly.No new information added.
 
Event Description
Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse event and product complaints (pcs), with additional information from the initial reporter, concerned a 64-years-old male patient of unknown origin.Medical history included father got diabetes.Previous drug adverse reaction and family drug reaction were none.Concomitant medication included metformin for diabetes.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100u/ml) from cartridge formulation, subcutaneously at twice daily (28 units in morning, 24 units in night) from 2000 or 2010 or 2011 (10-20 years ago).On an unknown date in 2010 he started taking human insulin isophane suspension 70%/human insulin 30% via reusable device (humapen ergo ii; tone blue).On an unknown date in 2010 he was hospitalized (specific reason was not provided).In the beginning, when pressed the humapen ergo ii it was going down unit by unit and it would slide down a lot all at once when near to the end of the injection.There was no clicking sound when the injection pen was pressed ((b)(4), unknown lot number).He used the first humapen ergo ii device till b)(6) or b)(6) 2017 (improper use of the device).On an unknown date in (b)(6) or (b)(6) 2017, he got the replacement of the first humapen ergo ii (tone blue) and started it in (b)(6) or (b)(6) 2017.On an unknown date in 2017, he was hospitalized for treatment again because the blood glucose was increased on an unknown date in about 2017.He stopped taking human insulin isophane suspension 70%/human insulin 30% by medical advice and changed to insulin lispro 50%/ insulin lispro protamine suspension 50% (humalog 50).As of b)(6) -2018, on an unknown date his blood glucose was fine and he was discharged from hospital.In the beginning when pressed the humapen ergo ii device it was going down unit by unit and it would slide down a lot all at once when near to the end of the injection in around b)(6) 2020.There was no clicking sound when the injection pen was pressed (b)(4), lot 1504d02).Information regarding further corrective treatment was not provided.He was recovering from the event.It was unknown if the human insulin isophane suspension 70%/human insulin 30% therapy would be restarted.The patient was the operator of the humapen ergo ii devices and his training status was not provided.The general humapen ergo ii model duration of use was about 10 years as the first humapen ergo ii was started sometime in 2010.The first suspect humapen ergo ii duration of use was approximately seven years as it was started somewhere in 2010 (improper use of the device).The second suspect humapen ergo ii (lot 1504d02) duration of use was approximately 3 years as it was started in (b)(6) 2017.The first suspect humapen ergo was replaced for the second suspect humapen ergo ii (lot 1504d02).The second suspect humapen ergo ii was returned on (b)(6) 2020.The initial reporting consumer did not know if the event of blood glucose increased was related to insulin human insulin isophane suspension 70%/human insulin 30% drug but thought the blood glucose increased was related to diet, and did not provide relatedness assessment between the event and humapen ergo ii devices.Update 17-sep-2020: additional information received on 14sep2020 and on 16sep2020 were processed at the same time.The information was provided from the initial reporter.Added event onset date for the event of blood glucose increased.Updated as reported causality for the event of blood glucose increased from no to unknown.Added two suspect device as humapen ergo ii.Updated insulin human mix 70 coding with cartridge formulation.Added one lab test.Added indication of insulin human insulin isophane suspension 70%/human insulin 30%.Updated causality statement and narrative with new information.Narrative was updated accordingly.Edit 22sep2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting and added contact log accordingly.No new information added.Update 11nov2020: additional information received on 11nov2020 from the global product complaint database.Entered device specific safety summaries (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information and device return status to not returned to manufacturer for b)(6) associated with an unknown lot of humapen ergo ii device.Updated the medwatch fields/ european and canadian (eu/ca) device information, malfunction from unknown to no, added date of manufacturer and reiterated date returned to manufacturer for the device for b)(6) associated with lot 1504d02 of humapen ergo ii device.Corresponding fields and narrative updated accordingly.
 
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(s) dated 11nov2020 in the b.5.Field.No further follow-up is planned.This is a downgrade report which no longer meets the criteria for expedited reporting.This report is associated with 1819470-2020-00126 since there is more than one device implicated.
 
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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 Key10568363
MDR Text Key215921592
Report Number1819470-2020-00125
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 consumer,foreign
Type of Report Initial,Followup
Report Date 11/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMS9557
Device Lot Number1504D02
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer09/16/2020
Date Manufacturer Received11/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age64 YR
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