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

Model Number MS9557

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problem Hyperglycemia (1905)

Event Date 03/31/2023

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)(4).This report is associated with product complaint: (b)(4).This spontaneous case reported by consumers who contacted the company to report adverse events and a product complaint (pc), concerned a 61-year-old (at the time of initial report) asian male patient.Medical history included diagnosed with diabetes mellitus in 2006.There was no previous drug adverse reaction and family drug adverse reaction.Concomitant medication included unspecified insulin for diabetes mellitus.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) from a cartridge via a reusable pen humapen ergo ii, at (b)(4) units in the morning and evening, twice daily, subcutaneously for the treatment of diabetes mellitus, beginning approximately on an unknown date in 2006.On an unknown date, he started using humapen ergo ii.On an unknown date in 2006, while on human insulin isophane suspension 70%/human insulin 30 therapy, when his blood glucose was high (exact values, units and reference ranges were unknown), he adjusted the dose of human insulin isophane suspension 70%/human insulin 30% upward, twice daily (exact dose was unknown) on his own.On an unknown date in 2011, he developed eye swelling, pain, high intraocular pressure, open-angle glaucoma of the right eye.In 2021, he sought medical treatment (the specific treatment was unknown) and the doctor prescribed unspecified eye drops and after using the medication, it got better.On an unknown date in 2023, he experienced anemia that led to uncontrolled blood glucose, and he was hospitalized due to the events.During the hospitalization, the highest adjustment of human insulin isophane suspension 70%/human insulin 30% was (b)(4) units in the morning and (b)(4) units in the evening, twice daily which further adjusted to 12 in the morning and 12 in the evening (twice daily) along with (b)(4) units of unspecified insulin at noon by the doctor.On an unknown date in (b)(6) 2023, he was discharged from the hospital and doctor suggested him to use the dosage twice a day, (b)(4) units in the morning and (b)(4) units in the evening.On an unknown date in (b)(6) 2023, he was not following doctor order and adjusted the dose of human insulin isophane suspension 70%/human insulin 30% used, twice a day, 10 in the morning and 10 in the evening.On (b)(6) 2024, he did not inject the human insulin isophane suspension 70%/human insulin 30 due to injection pen malfunction (pc number: (b)(4) /lot number: 1710d01).Further information regarding the corrective treatment for remain events was unknown.He was recovering from the events of open-angle glaucoma and eye swelling, and outcome of the remaining events were unknown.On (b)(6) 2024, the human insulin isophane suspension 70%/human insulin 30% treatment was discontinued, and it was unknown if he resumed the treatment or not.The operator of the humapen ergo ii was unknown and his/her training status was not provided.The humapen ergo ii general model duration and suspect duration of use was not reported.The action taken with humapen ergo ii and its return status were not provided.The initial reporting consumers did not know the relatedness for all the events with human insulin isophane suspension 70%/human insulin 30% therapy.The reporting consumers considered that the event of missed dose was due to product complaint issue of humapen ergo ii while did not report any relatedness for remaining events with humapen ergo ii device.Edit 13-feb-2024: upon review of the information received on 25-jan-2024, corrected the device distributed within the following countries and add the follow-up information-further investigations in euca field for humapen ergo ii device only.Edit 13feb2024: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.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 (s) dated 29feb2024 in the b.5.Field.No further follow-up is planned.Evaluation summary a male patient reported that the cartridge holder screw thread of his humapen ergo ii was broken and cracked (connecting to the screw thread opening at the needle area) in the evening of 24-jan-2024.On an unknown date in 2023, he experienced abnormal blood glucose.The investigation of the returned device (batch 1710d01, manufactured october 2017) found the cartridge holder thread end was cracked and the needle thread ends of the cartridge holder were missing.The damage to the cartridge holder rendered the device non-functional.Malfunction confirmed.Cartridge holders receive 100% in-process visual inspection during manufacturing of the device.The damage is attributed to excessive force applied in the field.There is evidence of improper use.The damage to the cartridge holder, rendering the device non-functional, is consistent with damage while in the field.This damage is not likely relevant to the event of abnormal blood glucose since the damage occurred after the event of abnormal blood glucose.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case reported by consumers who contacted the company to report adverse events and a product complaint (pc), concerned a 61-year-old (at the time of initial report) asian male patient.Medical history included diagnosed with diabetes mellitus in 2006.There was no previous drug adverse reaction and family drug adverse reaction.Concomitant medication included unspecified insulin for diabetes mellitus.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) from a cartridge via a reusable pen humapen ergo ii, at 6-7 units in the morning and evening, twice daily, subcutaneously for the treatment of diabetes mellitus, beginning approximately on an unknown date in 2006.On an unknown date, he started using humapen ergo ii.On an unknown date in 2006, while on human insulin isophane suspension 70%/human insulin 30 therapy, when his blood glucose was high (exact values, units and reference ranges were unknown), he adjusted the dose of human insulin isophane suspension 70%/human insulin 30% upward, twice daily (exact dose was unknown) on his own.On an unknown date in 2011, he developed eye swelling, pain, high intraocular pressure, open-angle glaucoma of the right eye.In 2021, he sought medical treatment (the specific treatment was unknown) and the doctor prescribed unspecified eye drops and after using the medication, it got better.On an unknown date in 2023, he experienced anemia that led to uncontrolled blood glucose, and he was hospitalized due to the events.During the hospitalization, the highest adjustment of human insulin isophane suspension 70%/human insulin 30% was 14 units in the morning and 14 units in the evening, twice daily which further adjusted to 12 in the morning and 12 in the evening (twice daily) along with 10 units of unspecified insulin at noon by the doctor.On an unknown date in (b)(6) 2023, he was discharged from the hospital and doctor suggested him to use the dosage twice a day, 12 units in the morning and 12 units in the evening.On an unknown date in (b)(6) 2023, he was not following doctor order and adjusted the dose of human insulin isophane suspension 70%/human insulin 30% used, twice a day, 10 in the morning and 10 in the evening.On (b)(6) 2024, he did not inject the human insulin isophane suspension 70%/human insulin 30 due to injection pen malfunction (pc number: 6953419/lot number: 1710d01).Further information regarding the corrective treatment for remain events was unknown.He was recovering from the events of open-angle glaucoma and eye swelling, and outcome of the remaining events were unknown.On (b)(6) 2024, the human insulin isophane suspension 70%/human insulin 30% treatment was discontinued, and it was unknown if he resumed the treatment or not.The operator of the humapen ergo ii was unknown and his/her training status was not provided.The humapen ergo ii general model duration and suspect duration of use was approximately 6 years.The action taken with humapen ergo ii were not provided.Humapen ergo ii was returned to manufacturer on 29jan2024.The initial reporting consumers did not know the relatedness for all the events with human insulin isophane suspension 70%/human insulin 30% therapy.The reporting consumers considered that the event of missed dose was due to product complaint issue of humapen ergo ii while did not report any relatedness for remaining events with humapen ergo ii device.Edit 13-feb-2024: upon review of the information received on 25-jan-2024, corrected the device distributed within the following countries and add the follow-up information-further investigations in euca field for humapen ergo ii device only.Edit 13feb2024: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 29feb2024: additional information received on 27feb2024 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 1710d01 of humapen ergo ii.Updated malfunction from unknown to yes, improper use or storage from no to yes.Added date of manufacturer, device return status to returned to manufacturer, and date returned to manufacturer for the device.Corresponding fields and narrative updated accordingly.

• 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: catherine cassidy ; lilly corporate center; indianapolis 46285 ; 3174332191
• MDR Report Key: 18735506
• MDR Text Key: 335749918
• Report Number: 1819470-2024-00007
• 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,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1710D01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2017
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian