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

Model Number MS9557

Device Problems Mechanical Jam (2983); Insufficient Information (3190)

Patient Problem Hypoglycemia (1912)

Event Type  Injury  

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case reported by consumer who contacted the company to report adverse events and a product complaint (pc), concerned an 83-year-old (at the time of initial report) chinese han female patient.Medical histories included myocardial infarction and cerebral thrombosis.She also underwent bypass for heart disease.She did not have previous drug adverse reaction and family drug adverse reaction.Concomitant medication included metformin used for an unknown indication.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) from a cartridge via a reusable pen humapen ergo ii, at 8 units in morning and 10 units in the evening, subcutaneously for the treatment of diabetes mellitus and beginning on an unknown date in 2013.On an unknown date in 2013, she started using humapen ergo ii (considered improper use).On an unknown date, while on human insulin isophane suspension 70%/human insulin 30 therapy, she experienced the condition of hypoglycemia at 2.7 (units and reference ranges were unknown).On an unknown date, at one time she also had condition of hypoglycemia at 1.7 when she was resuscitated in the emergency room in hospital and was hospitalized for the same.Her mentality was also not good.The event of hypoglycemia at 1.7 was considered serious via life threatening reason by the company.On an unspecified date, the dosage was changed to 8 units at noon daily due to hypoglycemia under the doctor's advice.Since 29-oct-2023, she did not administer the human insulin isophane suspension 70%/human insulin 30% dosages due to humapen ergo ii malfunction (pc number: 6796362 and lot number: 0910d02).Further information regarding the corrective treatment was unknown.She did not recover from the events of mental impairment and missed dose while outcome of the remaining events was unknown.The status of human insulin isophane suspension 70%/human insulin 30% treatment was dose decreased.The operator of the humapen ergo ii was patient and her training status was not provided.The humapen ergo ii general model duration and suspect duration of use was approximately 10 years.The action taken with humapen ergo ii and its return status were not provided.The initial reporting consumer did not know if the events were related with human insulin isophane suspension 70%/human insulin 30% drug.The reporting consumer considered 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.Update 15-nov-2023: information received on 14-nov-2023 from the local affiliate did not include medically significant information only the notification that multiple attempts to contact the reporter were made without success.No changes were made to the case.Edit (b)(6) 2023: updated medwatch and european and canadian (eu/ca) 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.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case reported by consumer who contacted the company to report adverse events and a product complaint (pc), concerned an 83-year-old (at the time of initial report) chinese han female patient.Medical histories included myocardial infarction and cerebral thrombosis.She also underwent bypass for heart disease.She did not have previous drug adverse reaction and family drug adverse reaction.Concomitant medication included metformin used for an unknown indication.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) from a cartridge via a reusable pen humapen ergo ii, at 8 units in morning and 10 units in the evening, subcutaneously for the treatment of diabetes mellitus and beginning on an unknown date in 2013.On an unknown date in 2013, she started using humapen ergo ii (considered improper use).On an unknown date, while on human insulin isophane suspension 70%/human insulin 30 therapy, she experienced the condition of hypoglycemia at 2.7 (units and reference ranges were unknown).On an unknown date, at one time she also had condition of hypoglycemia at 1.7 when she was resuscitated in the emergency room in hospital and was hospitalized for the same.Her mentality was also not good.The event of hypoglycemia at 1.7 was considered serious via life threatening reason by the company.On an unspecified date, the dosage was changed to 8 units at noon daily due to hypoglycemia under the doctor's advice.Since (b)(6) 2023, she did not administer the human insulin isophane suspension 70%/human insulin 30% dosages due to humapen ergo ii malfunction (pc number: 6796362 and lot number: 0910d02).Further information regarding the corrective treatment was unknown.She did not recover from the events of mental impairment and missed dose while outcome of the remaining events was unknown.The status of human insulin isophane suspension 70%/human insulin 30% treatment was dose decreased.The operator of the humapen ergo ii was patient and her training status was not provided.The humapen ergo ii general model duration and suspect duration of use was approximately 10 years.The action taken with humapen ergo ii were not provided and was returned to manufactuer.The investigation of the returned device found the device met functional requirements.No malfunction was identified.The initial reporting consumer did not know if the events were related with human insulin isophane suspension 70%/human insulin 30% drug.The reporting consumer considered 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.Update 15-nov-2023: information received on 14-nov-2023 from the local affiliate did not include medically significant information only the notification that multiple attempts to contact the reporter were made without success.No changes were made to the case.Edit 17nov2023: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 20nov2023: additional information received on 13nov2023 from the global product complaint database was processed together.Entered device specific safety summary (dsss).Updated the medwatch fields device information, device malfunction from unknown to no.Added date of manufacture for the humapen ergo ii (batch 0910d02) associated with (b)(4) which was returned to manufacturer.The date of return was updated.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 dated 20nov2023 in the b.5.Field.No further follow-up is planned.Evaluation summary: a family member of a female patient reported that the injection button of a humapen ergo ii could not be pressed down.On (b)(6) 2023, the patient's family member primed it by her/himself and used this pen reluctantly.The patient did not administer the human insulin due to humapen ergo ii malfunction.The patient experienced hypoglycemia.The investigation of the returned device (batch 0910d02, manufactured october 2009) found the device met functional requirements.No malfunction was identified.The patient used same humapen ergo ii for approximately 10 years.The core instructions for use state the humapen ergo ii has been designed to be used for up to 3 years after first use.The core instructions for use also state to always carry a spare insulin pen in case your pen is lost or damaged.There is evidence of improper use.The patient used the device beyond the recommended use period.This misuse is not likely relevant to the complaint since the device functioned normally, nor to the event of hypoglycemia.

• 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: 18161897
• MDR Text Key: 328424166
• Report Number: 1819470-2023-00077
• 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: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• 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: 0910D02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2009
• 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; Life Threatening
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian