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

Model Number MS9557

Device Problems Fluid/Blood Leak (1250); Insufficient Information (3190)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

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 an adverse event and a product complaint (pc), concerns a male patient of unknown age and ethnicity.Medical history and concomitant medications were not provided.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog 75/25) via cartridge with humapen ergo ii, subcutaneously for the treatment of diabetes mellitus, beginning in (b)(6) 2022.Dose and frequency were not provided.On an unknown date, while on insulin lispro protamine suspension 75%/insulin lispro 25% therapy, he experienced high blood glucose levels (values, units and reference ranges were not provided) due to the humapen ergo ll malfunctioning (lot: 1903d05, pc: pending), sometimes the needle missed a drop after the injection was completed and sometimes it missed two drops (incorrect dose administered), the injection dose maybe was not enough, the blood glucose was elevated and could not be lowered, hence, he was hospitalized and just discharged.He has not recovered from the event.Insulin lispro protamine suspension 75%/insulin lispro 25% therapy was continued with no change.Information regarding corrective treatment, and additional hospitalization details, such as admission and discharge dates, were not provided.Follow-up was not possible as the reporter refused to be contacted and no treating physician contact details were provided.Patient was the operator of the humapen ergo ii and his training status were unknown.The device model duration of use was not reported and the suspect humapen ergo ii duration of use was approximately 1 year.It was unknown if the use of the suspect humapen ergo ii was continued and if it was available for return.If device is returned, evaluation will be performed to determine if a malfunction has occurred.The reporting consumer did not know if the events were related to the insulin lispro protamine suspension 75%/insulin lispro 25% therapy, nor with the suspect humapen ergo ii.Update 18-sep-2023: information was received via affiliate on 12-sep-2023.No new medically significant information was added to the case.Edit 18-sep-2023: upon review of information provided on 12-sep-2023, narrative was corrected from (humulin 75/25) to (humalog 75/25).No further changes were made to the case.Edit 19sep2023: updated medwatch fields for expedited device reporting.No new information added.

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.

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 26sep2023 in the b.5.Field.No further follow-up is planned.Evaluation summary: pharmacy staff and family members of a male patient reported regarding the patient's humapen ergo ii device: "a drop of insulin would leak out after the injection in around (b)(6) 2023, sometimes 2 drops would leak out, while sometimes when he did not inject, it would also leak, and the injection dose wasn't enough." the patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch 1903d05, manufactured march 2019).Malfunction unknown.A complaint history review did not identify any atypical findings with regard to leaking after injection from device or dose accuracy issues.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.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 an adverse event and a product complaint (pc), concerns a male patient of unknown age and ethnicity.Medical history and concomitant medications were not provided.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog 75/25) via cartridge with humapen ergo ii, subcutaneously for the treatment of diabetes mellitus, beginning in (b)(6) 2022.Dose and frequency were not provided.On an unknown date, while on insulin lispro protamine suspension 75%/insulin lispro 25% therapy, he experienced high blood glucose levels (values, units and reference ranges were not provided) due to the humapen ergo ll malfunctioning (lot: 1903d05, (b)(4)), sometimes the needle missed a drop after the injection was completed and sometimes it missed two drops (incorrect dose administered), the injection dose maybe was not enough, the blood glucose was elevated and could not be lowered, hence, he was hospitalized and just discharged.He has not recovered from the event.Insulin lispro protamine suspension 75%/insulin lispro 25% therapy was continued with no change.Information regarding corrective treatment, and additional hospitalization details, such as admission and discharge dates, were not provided.Follow-up was not possible as the reporter refused to be contacted and no treating physician contact details were provided.Patient was the operator of the humapen ergo ii and his training status were unknown.The device model duration of use was not reported and the suspect humapen ergo ii duration of use was approximately 1 year.It was unknown if the use of the suspect humapen ergo ii was continued.Humapen ergo ii device did not return to manufacturer.The reporting consumer did not know if the events were related to the insulin lispro protamine suspension 75%/insulin lispro 25% therapy, nor with the suspect humapen ergo ii.Update 18-sep-2023: information was received via affiliate on 12-sep-2023.No new medically significant information was added to the case.Edit 18-sep-2023: upon review of information provided on 12-sep-2023, narrative was corrected from (humulin 75/25) to (humalog 75/25).No further changes were made to the case.Edit 19sep2023: updated medwatch fields for expedited device reporting.No new information added.Update 26sep2023: additional information received on 21sep2023 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields, added pc number into the narrative for the suspect humapen ergo ii device associated with (b)(4).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: 17774011
• MDR Text Key: 323733491
• Report Number: 1819470-2023-00067
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2023

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: Lay User/Patient
• Device Model Number: MS9557
• Device Lot Number: 1903D05
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 09/21/2023
• Supplement Dates FDA Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2023
• 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 Sex: Male