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

Model Number	MS9557
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Serious Injury
Event or Problem 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 a product complaint (pc), concerns a male patient of unknown age and ethnicity.Medical history included diabetes.Concomitant medications included insulin glulisine and insulin aspart for unspecified indication.The patient received insulin lispro (rdna origin) injections (humalog) via cartridge with humapen ergo ii, beginning approximately in (b)(6) 2024.Dose, frequency, route of administration and indication for use were not provided.Approximately on (b)(6) 2024, he started to received hemodialysis in the hospital due to diabetes (as reported).This event was considered serious by the company due to its medical significance.On an unspecified date, the humapen ergo ii was rigid and he had difficulty to perform the application (lot number 2112d04 / (b)(4)), therefore he was not able to administer his dose.As of (b)(6) 2024, he has been hospitalized since (b)(6) 2024 and clarified that the reason for hospitalization is to perform hemodialysis.Information regarding outcome of the events, corrective treatment, insulin lispro therapy status and additional details were not provided.The operator of the humapen ergo ii was the patient, and his training status was not provided.The general humapen ergo ii model duration of use and the suspect humapen ergo ii duration of use were not provided.The suspect humapen ergo ii was not returned to the manufacturer for investigation.The reporting consumer did not relate the diabetes event with insulin lispro therapy and did not provide an opinion of relatedness with humapen ergo ii.The reporting consumer did not provide an opinion of relatedness between the remaining event and insulin lispro therapy or the humapen ergo ii.Update 31-oct-2024: this case was determined to be non-valid as there was no identifiable adverse event reported and only medical procedure and product dose omission issue described.Update 08-nov-2024: this case was initially determined to be non-valid (no event).Additional information was received from the initial reporter in the response of the follow-up questionnaire on 06-nov-2024 that had a serious event.Added the serious event of diabetes, suspect device, insulin glulisine and insulin aspart as concomitant medication.Updated narrative accordingly.Update 14-nov-2024: additional information was received from initial reporting consumer on 13-nov-2024.Added information regarding hemodialysis in the narrative.Updated the case with new information.Edit 19-nov-2024: upon internal review of previous information received on 06-nov-2024 follow up checked as significant for device.Update 27nov2024: additional information received on 22nov2024 from the global product complaint database.Entered device specific safety summary (dsss) for humapen ergo ii device associated with (b)(4), lot 2112d04.Updated the medwatch fields/ european and canadian (eu/ca) device information and device return status to not returned to manufacturer.Added date of manufacturer for the device.Corresponding fields and narrative updated accordingly.
Additional 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 27nov2024 in the b.5.Field.No further follow-up is planned.Evaluation summary: a male patient reported that in (b)(6) 2024 the injection button of his humapen ergo ii device "was rigid and he had difficulty to perform the application" and he was unable to administer his dose.The patient experienced diabetes mellitus.The device was not returned to the manufacturer for investigation (batch 2112d04, manufactured december 2021).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.However, with the guidance of a trained professional, troubleshooting was performed, and the pen functioned normally and was fit for use.The patient reported the reuse of needles and storing the pen with the needle attached.The core instructions for use state to use a new needle for each injection, to remove the needle after every use, and to not store the pen with the needle attached.There is evidence of improper use.The patient stored the pen with the needle attached and reused needles.Needle reuse may be relevant to the complaint issue of difficulty to perform the application and administer the dose.It is unknown if this misuse is relevant to the complaint or the event of diabetes mellitus.

• Brand Name: HUMAPEN ERGO II
• Common Device Name: 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, IN 46285 ; 3174332191
• MDR Report Key: 20860154
• Report Number: 1819470-2024-00063
• Device Sequence Number: 13004797
• Product Code: FMF
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K151686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: MS9557
• Device Lot Number: 2112D04
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/31/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic