MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO II; FOR TREATMENT PURPOSES

Model Number MS9557

Device Problems Failure to Deliver (2338); Mechanical Jam (2983); Mechanics Altered (2984); Patient Device Interaction Problem (4001)

Patient Problem Hyperglycemia (1905)

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

Lilly case id: (b)(6).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via patient support program (psp), concerned a 57-years-old asian female patient.Medical history included cataract.Concomitant medication include insulin human for diabetes mellitus.The patient received human insulin isophane suspension (rdna origin) injection (humulin nph, 100u/ml) from a cartridge via a reusable pen (humapen ergo ii), 4u daily at night, applied via subcutaneous route, used for the treatment of diabetes mellitus, beginning on an unknown date.She also received human insulin (rdna origin) injection (humulin r, 100u/ml) from a cartridge via a reusable pen (humapen ergo ii), 20u every morning, noon and night, thrice daily, applied via subcutaneous route, used for the treatment of diabetes mellitus, beginning on an unknown date in 2017 or 2018.She started humapen ergo ii from (b)(6) 2018.On an unknown date, in 2017-2018, she had cataract.On an unknown date while on human insulin isophane suspension and human insulin therapies, her blood sugar was high and her fasting blood sugar was 12 (units and reference range not provided) for which she was admitted to the hospital on an unknown date.Sometime in (b)(6) 2019, the injection button of humapen ergo ii pen could not pushed down ((b)(4)/batch number 1804d03).It was noted, she re-used the needle which caused the issue.She changed to new needle and the issue resolved.She was discharged from the hospital on an unknown date.On an unknown date in (b)(6) 2022, after the spring festival, her cataract was more and more severe.On an unknown date in (b)(6) 2022, the black screw rod of her humapen ergo 2 injection pen could rotate but not move forward.The medicine liquids did not move, and there was the situation that so much medicine left because she was not clear that the injection pen had been faulty ((b)(4), batch 1804d03).For one week, the medicine liquids were not injecting into the body, and she appeared dizziness and blood glucose increasing.Further information regarding hospitalization, corrective treatment and event outcome was not provided.The human insulin therapy was discontinued in (b)(6) 2022 and human insulin isophane suspension was continued.The patient was the operator of the humapen ergo ii and her training status was unknown.The general humapen ergo ii duration of use was not provided but the suspect device duration of use was approximately four months (started on (b)(6) 2018).The suspect humapen ergo ii device associated with product complaint (b)(4) was continued, thus the device was not returned to the manufacturer while the status of second humapen ergo 2 was not provided and its return was expected.The reporting consumer considered the event of blood glucose increased (first episode) as related and did not provide the relatedness of remaining events of remaining events with human insulin isophane suspension treatment.The reporting consumer did not provide the relatedness of blood glucose increased (first episode) while did not know if the remaining events were related with human insulin therapy.The reporting consumer related the event of missed dose with humapen ergo 2 device and did not provide any opinion of relatedness for the remaining events with humapen ergo ii device.Update (b)(6) 2019: initial and follow-up information received on (b)(6) 2019 was processed together.Update (b)(6) 2019: additional information received on (b)(6) 2019 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.Upon review, the suspect device age was updated from unknown to approximately four months.Edit (b)(6) 2019: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update (b)(6) 2021: additional information was received from the initial consumer reporter via the psp on (b)(6) 2022.Added patient demographics (age, height, weight, and ethnicity), a medical history, additional suspect of insulin human and a suspect humapen ergo 2, four non serious events of dizziness, cataract aggravated, blood glucose increased and missed dose.Updated narrative with new information.Edit (b)(6) 2022: updated medwatch fields for expedited device reporting.No new information added.

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 57-years-old asian female patient.Medical history included cataract.Concomitant medication include insulin human for diabetes mellitus.The patient received human insulin isophane suspension (rdna origin) injection (humulin nph, 100u/ml) from a cartridge via a reusable pen (humapen ergo ii), 4u daily at night, applied via subcutaneous route, used for the treatment of diabetes mellitus, beginning on an unknown date.She also received human insulin (rdna origin) injection (humulin r, 100u/ml) from a cartridge via a reusable pen (humapen ergo ii), 20u every morning, noon and night, thrice daily, applied via subcutaneous route, used for the treatment of diabetes mellitus, beginning on an unknown date in 2017 or 2018.She started humapen ergo ii from (b)(6) 2018.On an unknown date, in 2017-2018, she had cataract.On an unknown date while on human insulin isophane suspension and human insulin therapies, her blood sugar was high and her fasting blood sugar was 12 (units and reference range not provided) for which she was admitted to the hospital on an unknown date.Sometime in (b)(6) 2019, the injection button of humapen ergo ii pen could not pushed down ((b)(4)/batch number 1804d03).It was noted, she re-used the needle which caused the issue.She changed to new needle and the issue resolved.She was discharged from the hospital on an unknown date.On an unknown date in (b)(6) 2022, after the spring festival, her cataract was more and more severe.On an unknown date in (b)(6) 2022, the black screw rod of her humapen ergo 2 injection pen could rotate but not move forward.The medicine liquids did not move, and there was the situation that so much medicine left because she was not clear that the injection pen had been faulty ((b)(4) , batch 1804d03).For one week, the medicine liquids were not injecting into the body, and she appeared dizziness and blood glucose increasing.Further information regarding hospitalization, corrective treatment and event outcome was not provided.The human insulin therapy was discontinued in (b)(6) 2022 and human insulin isophane suspension was continued.The patient was the operator of the humapen ergo ii and her training status was unknown.The general humapen ergo ii duration of use was not provided but the suspect device duration of use was approximately four months (started on (b)(6) 2018).The suspect humapen ergo ii device associated with product complaint (b)(4) was continued, thus the device was not returned to the manufacturer.The second humapen ergo 2 ((b)(4), batch 1804d03) was returned to manufacturer.And was evaluated.The reporting consumer considered the event of blood glucose increased (first episode) as related and did not provide the relatedness of remaining events of remaining events with human insulin isophane suspension treatment.The reporting consumer did not provide the relatedness of blood glucose increased (first episode) while did not know if the remaining events were related with human insulin therapy.The reporting consumer related the event of missed dose with humapen ergo 2 device and did not provide any opinion of relatedness for the remaining events with humapen ergo ii device.Update 16-apr-2019: initial and follow-up information received on 10-apr-2019 was processed together.Update 23apr2019: additional information received on 19apr2019 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.Upon review, the suspect device age was updated from unknown to approximately four months.Edit 23apr2019: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 31-jul-2021: additional information was received from the initial consumer reporter via the psp on 26-jul-2022.Added patient demographics (age, height, weight, and ethnicity), a medical history, additional suspect of insulin human and a suspect humapen ergo 2, four non serious events of dizziness, cataract aggravated, blood glucose increased and missed dose.Updated narrative with new information.Edit 05aug2022: updated medwatch fields for expedited device reporting.No new information added.Update 01sep2022: additional information received on 26aug2022 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information for (b)(4) associated with lot number 1804d03 of humapen ergo ii.Updated malfunction from unknown to no, improper use and storage from yes to no, date of manufacturer, device return status to returned to manufacturer, and date returned to manufacturer for the 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 01sep2022 in the b.5.Field.No further follow-up is planned.This report is associated with mdr 1819470-2019-00078 since there is more than one device implicated.This is a downgrade report that no longer meets the criteria for expedited reporting.Evaluation summary: a female patient reported the injection screw of her humapen ergo ii device rotated when the injection button was pressed, but the injection screw did not move forward.The insulin was not injected.The patient experienced increased blood glucose.Investigation of the returned device (batch 1804d03, manufactured april 2018) found the device met functional requirements.No malfunction was identified.There is no evidence of improper use or storage.

• Brand Name: HUMAPEN ERGO II
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): TECH GROUP NORTH AMERICA INC. DBA WEST; 640 south rockford drive; tempe AZ 85281
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 15179547
• MDR Text Key: 297413857
• Report Number: 1819470-2022-00054
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9557
• Device Lot Number: 1804D03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian