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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); Use of Device Problem (1670); No Flow (2991)
Patient Problem Hyperglycemia (1905)
Event Date 03/22/2020
Event Type  Injury  
Manufacturer Narrative
If device is returned, evaluation will be performed to determine if a malfunction has occurred.A follow-up report will be submitted when the final evaluation is completed as necessary.
 
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 events and product complaints (pc), concerned a (b)(6) year-old male patient of an unknown ethnicity.Medical history included heart disease and patient mother had diabetes mellitus.Medical history included that he was hospitalized due to high blood glucose in 2018.Concomitant medication included acarbose and metformin, both for the treatment of diabetes mellitus.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30) from cartridge via humapen ergo ii (grey and dark blue) reusable device, 10 units at night, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date in 2018.On an unknown date he was switched to 12 units daily at night as per physician advice since an unknown date in 2018 to 2019.Later, due to the high blood glucose (postprandial blood glucose 21, 22), the dose was changed by himself to once a day and night 18 at one time, and the high blood glucose (postprandial blood glucose 21 and 22) had recovering.On an unknown date, while on human insulin isophane suspension 70%/human insulin 30% therapy, he had weight loss.On (b)(6) 2020 or (b)(6) 2020, he patient was hospitalized due to the high postprandial blood glucose value (blood glucose value 24, 25) (second episode).After being hospitalized, according to the doctor instructions the dose changed from once a day, night 18 at one time to twice a day (morning 14 and night 16), and was discharged on (b)(6) 2020.High blood glucose (the blood glucose value was 24,25) had recovering.On an unknown date in (b)(6) 2020, humapen ergo ii was not easy to use and when it was turned to 10 and no medication came out below and the black spiral rod did not move.The injection screw of the insulin injection pen could not move while the injection button could be pushed down, and the insulin could not flow out.He changed the needle, primed with two international unit before injection and issue was solved and due to pen issue he did not know if medication was injected into his body (lot: 1510d02, pc number: (b)(4)).On (b)(6) 2020, his blood glucose was high and postprandial blood glucose value was 29 and injection felt like as no injection was injected.On (b)(6) 2020, he suspected that insulin had not been injected in due to injection pen failure, which resulted in high postprandial blood sugar (the blood glucose value was 20-30).At present, high postprandial blood sugar (the blood glucose value was 20-30) had recovering.Information regarding corrective treatments and outcome the remaining events was not provided.Therapy status of human insulin isophane suspension 70%/human insulin 30% was ongoing.The patient was the operator of the reusable humapen ergo ii device and his training status was not provided.The general reusable humapen ergo ii device model duration of use and suspect reusable device duration of use were unknown but started in 2018 or 2019.The action taken with suspect reusable humapen ergo ii device was unknown.The status of suspect reusable humapen ergo ii device was ongoing and the return status of suspect reusable humapen ergo ii device was not provided.The initial reporting consumer considered that the events of blood sugar increased (second episode), missed dose and blood glucose increased (third episode) were related to insulin human mix 70/30 drug.The initial reporting consumer did not provide an assessment of relatedness between the remaining events and human insulin isophane suspension 70%/human insulin 30% drug and humapen ergo ii and related the events of missed dose with product complaint associated with humapen ergo ii.This case was cross referenced with the following case: (b)(4) (same patient).Update 27-apr-2020: both the information received on 22-apr-2020 was processed together at the time of initial report.Update 07-may-2020: additional information was received from the initial reporting consumer on 05-may-2020.This case was upgraded from non-serious to serious upon addition of the serious event of blood sugar increased (second episode).Added two non-serious events of missed dose and blood glucose increased (third episode).Added lab two tests, one medical history and two dosage regimen of human insulin mix 70/30.Completed eu/(b)(6) field in the pre-existing humapen ergo ii with similar lot number.Updated action taken from unknown to dose increased.Updated causality statement and narrative with new information.Edit 08may2020: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.Edit 11-may-2020: upon review of the information received on 05-may-2020, the as determined causality for the event of missed dose was updated from yes to no as per company assessment of relatedness statement.No other changes were made to the case.Update 11-may-2020: information received on 05-may-2020 from the initial reporter without new adverse event information.
 
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 (b)(6) 2020 in the b.5.Field.This is a downgrade report, which no longer meets the criteria for expedited reporting.No further follow-up is planned.Evaluation summary: a male patient reported that the injection screw of his humapen ergo ii could not move while the injection button could be pushed down, and the insulin could not flow out.Due to pen issue he did not know if medication was injected into his body.He experienced high blood glucose.With the guidance of a trained professional, troubleshooting was performed, including priming the device, and the issue was resolved.The investigation of the returned device (batch 1510d02, manufactured october 2015) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.The core instructions for use also states if any of the parts of your humapen ergo ii appear broken or damaged, do not use, and to always carry a spare insulin pen in case your pen is lost or damaged.There is no evidence of improper use or storage.
 
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 events and product complaints (pc), concerned a 56-year-old male patient of an unknown ethnicity.Medical history included heart disease and patient mother had diabetes mellitus.Medical history included that he was hospitalized due to high blood glucose in 2018.Concomitant medication included acarbose and metformin, both for the treatment of diabetes mellitus.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30) from cartridge via humapen ergo ii (grey and dark blue) reusable device, 10 units at night, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date in 2018.On an unknown date he was switched to 12 units daily at night as per physician advice since an unknown date in 2018 to 2019.Later, due to the high blood glucose (postprandial blood glucose 21, 22), the dose was changed by himself to once a day and night 18 at one time, and the high blood glucose (postprandial blood glucose 21 and 22) had recovering.On an unknown date, while on human insulin isophane suspension 70%/human insulin 30% therapy, he had weight loss.On (b)(6) 2020 or (b)(6) 2020, he patient was hospitalized due to the high postprandial blood glucose value (blood glucose value 24, 25) (second episode).After being hospitalized, according to the doctor instructions the dose changed from once a day, night 18 at one time to twice a day (morning 14 and night 16) and was discharged on (b)(6) 2020.High blood glucose (the blood glucose value was 24,25) had recovering.On an unknown date in (b)(6) 2020, humapen ergo ii was not easy to use and when it was turned to 10 and no medication came out below and the black spiral rod did not move.The injection screw of the insulin injection pen could not move while the injection button could be pushed down, and the insulin could not flow out.He changed the needle, primed with two international unit before injection and issue was solved and due to pen issue, he did not know if medication was injected into his body (pc number (b)(4), lot: number 1510d02).On (b)(6) 2020, his blood glucose was high and postprandial blood glucose value was 29 and injection felt like as no injection was injected.On (b)(6) 2020, he suspected that insulin had not been injected in due to injection pen failure, which resulted in high postprandial blood sugar (the blood glucose value was 20-30).At present, high postprandial blood sugar (the blood glucose value was 20-30) had recovering.Information regarding corrective treatments and outcome the remaining events was not provided.Therapy status of human insulin isophane suspension 70%/human insulin 30% was ongoing.The patient was the operator of the reusable humapen ergo ii device and his training status was not provided.The general reusable humapen ergo ii device model duration of use and suspect reusable device duration of use were unknown but the device (lot number 1510d02) was started in 2018 or 2019 (reported to have been less than two years ago).The suspect reusable humapen ergo ii device associated with product complaint (b)(4) was returned to the manufacturer on 12may2020.The initial reporting consumer considered that the events of blood sugar increased (second episode), missed dose and blood glucose increased (third episode) were related to insulin human mix 70/30 drug.The initial reporting consumer did not provide an assessment of relatedness between the remaining events and human insulin isophane suspension 70%/human insulin 30% drug and humapen ergo ii and related the events of missed dose with product complaint associated with humapen ergo ii.This case was cross referenced with the following case: (b)(4) (same patient).Update 27-apr-2020: both the information received on 22-apr-2020 was processed together at the time of initial report.Update 07-may-2020: additional information was received from the initial reporting consumer on 05-may-2020.This case was upgraded from non-serious to serious upon addition of the serious event of blood sugar increased (second episode).Added two non-serious events of missed dose and blood glucose increased (third episode).Added lab two tests, one medical history and two dosage regimen of human insulin mix 70/30.Completed eu/ca field in the pre-existing humapen ergo ii with similar lot number.Updated action taken from unknown to dose increased.Updated causality statement and narrative with new information.Edit 08may2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 11-may-2020: upon review of the information received on 05-may-2020, the as determined causality for the event of missed dose was updated from yes to no as per company assessment of relatedness statement.No other changes were made to the case.Update 11-may-2020: information received on 05-may-2020 from the initial reporter without new adverse event information.Update 23jun2020: additional information received on 22jun2020 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 no, 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), which was returned to the manufacturer on 12may2020.Corresponding fields and narrative updated accordingly.Update 24jun2020: additional information received on 23jun2020 from the global product complaint database.No new information added.
 
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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 Key10057655
MDR Text Key193739984
Report Number1819470-2020-00047
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 06/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMS9557
Device Lot Number1510D02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2020
Date Manufacturer Received06/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age56 YR
Patient Weight53
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