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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 Fluid/Blood Leak (1250); Leak/Splash (1354); Failure to Deliver (2338); Difficult or Delayed Activation (2577); Mechanical Jam (2983)
Patient Problem Hyperglycemia (1905)
Event Date 01/31/2019
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 1819470-2021-00024 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 with a product complaint, with additional information from initial reporter, concerned a (b)(6) year-old asian female patient.The medical history included anemia, hypoglycemia and her kidney was not good (as reported).The concomitant medications included acetylsalicylic acid for unknown indication, insulin aspart and glucobay (acarbose) for diabetes mellitus, and unspecified drug for blood vessel of brain (as reported).The patient received insulin lispro (humalog) cartridge via reusable pen, 16 iu each morning and 12 iu each evening, subcutaneously, for treatment of diabetes mellitus, beginning in 2016.In (b)(6) 2019, approximately three years after the starting of insulin lispro via humapen ergo ii (lot number 1310d01), the patient was hospitalized due to uncontrolled blood glucose and complications caused by diabetes as lumbago, rotten feet, high eye pressure caused by glaucomatous lesions and osteoporosis (as reported).It was provided her physician changed insulin lispro to insulin aspart during the hospitalization due to unknown reason.In 2020 the patient returned to use insulin lispro and the dose was changed to 18 iu each morning and 14 iu each evening via humapen ergo ii.It was provided patient also used her first humapen ergo ii (lot number 1310d01) again in 2020 (approximately four years after its first use) which injection button could not be pushed down after using it for some time, the liquid was not injected because of the pen malfunction (product complaint: (b)(4), lot number: 1310d01/ product complaint: (b)(4), lot number: 1310d01 ).Also, after the injection, there was leakage from the needle after it was pulled out.In (b)(6) 2020, unknown time after reintroduction of insulin lispro, the blood pressure was quite high (as reported), diastolic blood pressure was at 68 and systolic blood pressure was at 190 (units and normal range were not provided).The event of high blood pressure was considered serious by the company due to medically significant reasons.On an unspecified date, her insulin lispro dose was changed to 18 units in the morning and 16 units at night.Information regarding exams, corrective treatment and outcome of the events was not provided.It was unknown if any action was taken with insulin lispro due to the events and if it was ongoing.It was unknown who operated the device and if the operator was trained.The duration of use for this device model and suspect device (lot number 1310d01) was approximately four years.The suspect humapen ergo ii device associated with product complaint (b)(4) was not returned to the manufacturer.The reporting consumer did not know if the events were related to insulin lispro and did not provide any opinion of relatedness regarding humapen ergo ii.Edit 10feb2021: upon internal review on 10feb2021 it was corrected age of suspect device from three to approximately four years in the fourth paragraph from narrative.Corresponding field updated accordingly.Edit 10feb2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 12feb2021: additional information received on 11feb2021 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, and malfunction from unknown to no.Added date of manufacturer 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 23-jul-2021: additional information received on19-jul-2021 from initial reporter.Added: new dosage regimen (18u morning and 16u night), acarbose as concomitant medication.Updated patient's weight (b)(6) kg.Narrative was updated accordingly.Edit 10-aug2021: the suspect device was duplicated for product complaint processing purposes ((b)(4)).No further changes made in the case.Edit 12aug2021: updated medwatch 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 23sep2021 in the b.5.Field.No further follow-up is planned.This report is associated with 1819470-2021-00024 since there is more than one device implicated.Evaluation summary: a female patient reported that, in 2020, the injection button of her humapen ergo ii device could not be pushed down and "the liquid was not injected because of the pen malfunction" she also reported that after the injection, there was leakage from the needle after it was pulled out.In (b)(6) or (b)(6) 2019, the patient experienced abnormal blood glucose.The investigation of the returned device (batch 1310d01, manufactured october 2013) found the device met functional requirements.No malfunction was identified.The patient reported that she had used the device approximately four 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.
 
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 with a product complaint, with additional information from initial reporter, concerned a 75 year old asian female patient.The medical history included anemia, hypoglycemia and her kidney was not good (as reported).The concomitant medications included acetylsalicylic acid for unknown indication, insulin aspart and glucobay (acarbose) for diabetes mellitus, and unspecified drug for blood vessel of brain (as reported).The patient received insulin lispro (humalog) cartridge via reusable pen, 16 iu each morning and 12 iu each evening, subcutaneously, for treatment of diabetes mellitus, beginning in 2016.In (b)(6) 2019 or (b)(6) 2019, approximately three years after the starting of insulin lispro via humapen ergo ii (lot number 1310d01), the patient was hospitalized due to uncontrolled blood glucose and complications caused by diabetes as lumbago, rotten feet, high eye pressure caused by glaucomatous lesions and osteoporosis (as reported).It was provided her physician changed insulin lispro to insulin aspart during the hospitalization due to unknown reason.In 2020 the patient returned to use insulin lispro and the dose was changed to 18 iu each morning and 14 iu each evening via humapen ergo ii.It was provided patient also used her first humapen ergo ii (lot number 1310d01) again in 2020 (approximately four years after its first use) which injection button could not be pushed down after using it for some time, the liquid was not injected because of the pen malfunction (product complaint: (b)(4) lot number: 1310d01; product complaint: (b)(4) lot number: 1310d01).Also, after the injection, there was leakage from the needle after it was pulled out.In (b)(6) 2020, unknown time after reintroduction of insulin lispro, the blood pressure was quite high (as reported), diastolic blood pressure was at 68 and systolic blood pressure was at 190 (units and normal range were not provided).The event of high blood pressure was considered serious by the company due to medically significant reasons.On an unspecified date, her insulin lispro dose was changed to 18 units in the morning and 16 units at night.Information regarding exams, corrective treatment and outcome of the events was not provided.It was unknown if any action was taken with insulin lispro due to the events and if it was ongoing.It was unknown who operated the humapen ergo ii and if the operator was trained.The general device model and suspect device model duration of use for the humapen ergo ii (lot numbers 1310d01) was approximately four years.The suspect humapen ergo ii (lot number 1310d01) device associated with product complaint (b)(4) noted the issue resolved after trained professional troubleshooting.The suspect humapen ergo ii device (lot number 1310d01) associated with product complaint (b)(4) was returned to the manufacturer on (b)(6) 2021.The reporting consumer did not know if the events were related to insulin lispro and did not provide any opinion of relatedness regarding humapen ergo ii.Edit 10feb2021: upon internal review on 10feb2021 it was corrected age of suspect device from three to approximately four years in the fourth paragraph from narrative.Corresponding field updated accordingly.Edit 10feb2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 12feb2021: additional information received on 11feb2021 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, and malfunction from unknown to no.Added date of manufacturer 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 23jul2021: additional information received on19jul2021 from initial reporter.Added: new dosage regimen (18u morning and 16u night), acarbose as concomitant medication.Updated patient weight from 60 to 57.4kg.Narrative was updated accordingly.Edit 10aug2021: the suspect device was duplicated for product complaint processing purposes (b)(4).No further changes made in the case.Edit 12aug2021: updated medwatch fields for expedited device reporting and added contact log accordingly.No new information added.Update 23sep2021: additional information received on 20sep2021 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, device available for evaluation to returned to manufacturer, and added date returned manufacturer for the suspect humapen ergo ii device (lot number 1310d01) associated with product complaint (b)(4) which was returned to the manufacturer.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 Key12316609
MDR Text Key266378618
Report Number1819470-2021-00105
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 10/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9557
Device Lot Number1310D01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2021
Initial Date Manufacturer Received 07/19/2021
Initial Date FDA Received08/12/2021
Supplement Dates Manufacturer Received09/20/2021
Supplement Dates FDA Received10/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age75 YR
Patient Weight57
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