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

Model Number	MS9557
Medical Device Problem Codes	Failure to Deliver (2338); 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 product complaint (pc), concerned a 64-years-old (at the time of initial report) patient of unknown gender of han nationality.Medical histories included heart disease and hypertension.There was no previous drug adverse reaction and no family drug reaction.Concomitant medications included unspecified medication used for unknown indication.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) from cartridge (humalog 50, 300 iu/3ml), via a reusable pen (humapen ergo ii), at dose of 18 units in morning, 18 units in evening, subcutaneously, for treatment of diabetes mellitus, beginning on an unknown date in (b)(6) 2016.On an unknown date, according to advice of doctor dose of patient was changed to 24 units in morning and 24 units in evening.On an unknown date, after starting insulin lispro protamine suspension 50%/insulin lispro 50% therapy, patient's conditions of heart disease and hypertension worsened.On (b)(6) 2023, injection screw of humapen ergo ii could not move and she could not inject insulin lispro protamine suspension 50%/insulin lispro 50% (pc: 6350121; lot number: 1611d01).On an unknown date, patient's blood glucose was too high (values, units and reference range were not provided) and the patient was hospitalized to regulate blood glucose on (b)(6) 2023.The patient used same humapen ergo ii for approximately 76 months (considered as improper use).Information regarding corrective treatment, hospitalization details, outcome of the events and status of therapy was not provided.Patient was the operator the humapen ergo ii and her training status was not provided.The humapen ergo ii general model duration of use and the suspect humapen duration of use was approximately 76 months.Action taken with the suspect humapen was not provided and device was returned on 20feb2023.The initial reporting consumer did not know whether events were related with insulin lispro protamine suspension 50%/insulin lispro 50% therapy.The initial reporting consumer related the event of missed dose with suspect humapen ergo ii device issue and did not provide relatedness assessment of the remaining events with suspect humapen ergo ii device.Update 25-feb-2023: all information received on 17-feb-2023 and 20-feb-2023 were processed together.Update 06-mar-2023: additional information was received from initial reporter on 02-mar-2023.The case was upgraded to serious as event of blood glucose increased was updated to serious due to hospitalization criteria.Added eu/ca fields for humapen ergo ii device.Updated narrative accordingly.Update 27mar2023: additional information received on 21feb2023 from the global product complaint database.Entered device specific safety summary (dsss) for humapen ergo ii device associated with pc 6350121, lot 1611d01.Updated the medwatch fields/ european and canadian (eu/ca) device information and device return status to returned to manufacturer.Added date of manufacture, date of return to manufacturer for the device.The device malfunction was updated from unknown to no.Corresponding fields and narrative updated accordingly.
Additional Manufacturer Narrative
Narrative field: new, updated and corrected information is referenced within the update statements in report.Please refer to update statement dated 27mar2023 in the event field.No further follow-up is planned.Evaluation summary: the family of a patient reported that injection screw of humapen ergo ii could not move and insulin could not be injected.The patient experienced increased blood glucose.The investigation of the returned device (batch 1611d01, manufactured november 2016) found the device met functional requirements.No malfunction was identified.The patient used same humapen ergo ii for approximately 76 months, since october 2016.The core instructions for use state the humapen ergo ii has been designed to be used for up to 3 years after first use.There is evidence of improper use.The patient used the device beyond the recommended use period.This misuse may not be relevant to this complaint or to the events of increased blood glucose since the device met functional requirements.

• 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: chris davis ; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 16658165
• Report Number: 1819470-2023-00020
• Device Sequence Number: 7274702
• Product Code: FMF
• UDI-Device Identifier: 00300029673019
• UDI-Public: 00300029673019
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/31/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: MS9557
• Device Catalogue Number: MS9673
• Device Lot Number: 1611D01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2016
• 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: Hospitalization
• Patient Sex: Unknown
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian