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

Model Number MS9557

Device Problems Fracture (1260); Failure to Deliver (2338); Mechanical Jam (2983); Insufficient Information (3190)

Patient Problem Hyperglycemia (1905)

Event Date 09/30/2023

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 a consumer, who contacted the company to report adverse event and a product complaint, concerned a female patient of unknown age and origin.Medical history and concomitant medications were unknown.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) from a cartridge, administered subcutaneously, for the treatment of diabetes mellitus, via a reusable pen humapen ergo ii, beginning since an unknown date in 2011.Dosage regimen, therapy start date and frequency of administration of human insulin isophane suspension 70%/human insulin 30% was not provided.On an unknown date in 2021 or 2022, while on human insulin isophane suspension 70%/human insulin 30%, due to the malfunction of the injection pen, her blood glucose had been high and low for a while (the specific time of occurrence cannot be obtained).On an unknown date in (b)(6) 2023, while on human insulin isophane suspension 70%/human insulin 30%, her blood glucose was very high (the specific time of occurrence was unknown) and her blood sugar level was between more than 20 and 21 or 22, her glucose values were in the range of 20-30 and was hospitalized because of it (lot.No.1008d02, pc.No.6737843).As of (b)(6) 2023, she was still hospitalized (the specific length of hospitalization cannot be obtained).It was reported she started using humapen ergo ii since an unknown date in 2011(improper use).Further information regarding corrective treatment and hospitalization details were unknown.Outcome of blood glucose increased was unknown, whereas she had recovered from previous episodes of blood glucose increased and blood glucose decreased.Status of human insulin isophane suspension 70%/human insulin 30% therapy was ongoing.The patient was the operator of humapen ergo ii, and her training status was not provided.The general and suspect humapen ergo ii model duration of use was approximately 12 years.The action taken with suspect humapen was unknown and their return status was not provided.The reporting consumer did not know if the events were related with human insulin isophane suspension 70%/human insulin 30% and did not provide relatedness of events with humapen ergo ii.Edit 03oct2023: updated medwatch fields for expedited device reporting.No new information added.

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 adverse event and a product complaint, concerned a female patient of unknown age and origin.Medical history and concomitant medications were unknown.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) from a cartridge, administered subcutaneously, for the treatment of diabetes mellitus, via a reusable pen humapen ergo ii, beginning since an unknown date in 2011.Dosage regimen, therapy start date and frequency of administration of human insulin isophane suspension 70%/human insulin 30% was not provided.On an unknown date in 2021 or 2022, while on human insulin isophane suspension 70%/human insulin 30%, due to the malfunction of the injection pen, her blood glucose had been high and low for a while (the specific time of occurrence cannot be obtained).On an unknown date in (b)(6) 2023, while on human insulin isophane suspension 70%/human insulin 30%, her blood glucose was very high (the specific time of occurrence was unknown) and her blood sugar level was between more than 20 and 21 or 22, her glucose values were in the range of 20-30 and was hospitalized because of it (lot.No.1008d02, pc.No.(b)(4)).As of 26-sep-2023, she was still hospitalized (the specific length of hospitalization cannot be obtained).It was reported she started using humapen ergo ii since an unknown date in 2011(improper use).Further information regarding corrective treatment and hospitalization details were unknown.Outcome of blood glucose increased was unknown, whereas she had recovered from previous episodes of blood glucose increased and blood glucose decreased.Status of human insulin isophane suspension 70%/human insulin 30% therapy was ongoing.The patient was the operator of humapen ergo ii, and her training status was not provided.The general and suspect humapen ergo ii model duration of use was approximately 12 years.The action taken with suspect humapen was unknown and it returned to manufacturer.The reporting consumer did not know if the events were related with human insulin isophane suspension 70%/human insulin 30% and did not provide relatedness of events with humapen ergo ii.Edit 03oct2023: updated medwatch fields for expedited device reporting.No new information added.Update 17nov2023: additional information received on 16nov2023 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields, malfunction from unknown to yes, and device return status to returned to manufacturer; and added date of manufacture and date returned to manufacturer for the suspect humapen ergo ii device associated with p(b)(4).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(s) dated 17nov2023 in the b.5.Field.No further follow-up is planned.Evaluation summary female patient reported pen body under dose adjustment knob of humapen ergo ii was cracked, injection button could not be pushed down, medicine could not be pushed out.She experienced increased blood glucose.Investigation of returned device (batch 1008d02, manufactured aug 2010) found the pen housing was cracked and damaged, soft touch was de-bonded and damaged, lens/bezel was detached and missing, cartridge holder threads were cracked at device end.There was evidence of excessive force observed, along with exposure to an unknown chemical while in the field, for these issues.The cracked housing near lens/bezel attachment area indicates lens/bezel detachment was likely caused by impact against a hard surface or a tool.Due to this damage, no further testing could be conducted.Malfunction confirmed.Device was disassembled, and no damage was observed; however, foreign material was observed on multiple internal components.The observed internal contamination caused high injection force, which would have been detected during end of line testing for injection force.Foreign material was introduced while in the field and not during the manufacturing of the pen.The damage to device would have been detected post assembly during the 100% visual inspection and end of line testing process, and device would have been rejected.The observed internal contamination which caused high injection force would have been detected during end of line testing for injection force.Patient reported using the device for approximately 12 years.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 damage to the device is consistent with damage while in the field.Additionally, patient used the device beyond its approved use life.It is unknown if these misuses are relevant to the event of increased blood glucose.

• 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: 17870050
• MDR Text Key: 324913132
• Report Number: 1819470-2023-00070
• 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: 11/28/2023

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: 1008D02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/04/2023
• Supplement Dates Manufacturer Received: 11/16/2023
• Supplement Dates FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2010
• 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: Female