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

Model Number MS9557

Device Problems Leak/Splash (1354); Insufficient Information (3190)

Patient Problem Hypoglycemia (1912)

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 events and a product complaint (pc), concerned a female patient of unknown age and origin.Medical histories were unknown.Concomitant medications included plendil, yin'he'lv'se'tong'dao probiotics, si'xiao'wan (as reported) for unknown indications.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog, mix 50), from a cartridge via humapen ergo ii, at 18 units in the morning and 18 units in the evening, via subcutaneous injection for the treatment of diabetes mellitus beginning on an unknown date in 2019.On an unknown date in oct or nov-2023 (conflicting information), she started using humapen ergo ii.On an unspecified date, while on insulin lispro protamine suspension 50%/insulin lispro 50% therapy, the injection pen was leaking fluid, and the injection was not accurate (pc: 6947472/lot: unknown).On an unknown date, when she woke up one morning, she was dazed and fell on the floor, and her blood glucose value was only 1.6 (hypoglycemia) usually the lowest blood glucose values were 3-4 (units were unknown).Her heart was not good, she would get anxious and angry, had hypertension and hypotension, had hyperglycemia, constipation, could not sleep, and legs were not good.The events of hypoglycemia and fall were considered serious by the company due to their medically significant reason.The information regarding the corrective treatment and outcome of the events were unknown.The status of insulin lispro protamine suspension 50%/insulin lispro 50%treatment was continued.Follow up was not possible as the patient was unwilling to provide more information and treating physician contact details could not be obtained.The user of the humapen ergo ii was unknown and her/his training status was not provided.The humapen ergo ii model duration of use was not provided.The action taken with the suspect humapen ergo ii and its return status was unknown.The initial reporting consumer did not know if the events were related with insulin lispro protamine suspension 50%insulin lispro 50% drug.The reporting consumer considered that the event of incorrect dose administered was due to product complaint issue of humapen ergo ii and did not report any relatedness for remaining events with humapen ergo ii.Edit 09feb2024: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.

Event Description

Lilly case id: (b)(6).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), concerned a female patient of unknown age and origin.Medical histories were unknown.Concomitant medications included plendil, yin'he'lv'se'tong'dao probiotics, si'xiao'wan (as reported) for unknown indications.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog, mix 50), from a cartridge via humapen ergo ii, at 18 units in the morning and 18 units in the evening, via subcutaneous injection for the treatment of diabetes mellitus beginning on an unknown date in 2019.On an unknown date in oct or nov-2023 (conflicting information), she started using humapen ergo ii.On an unspecified date, while on insulin lispro protamine suspension 50%/insulin lispro 50% therapy, the injection pen was leaking fluid, and the injection was not accurate (pc: 6947472/lot: unknown).On an unknown date, when she woke up one morning, she was dazed and fell on the floor, and her blood glucose value was only 1.6 (hypoglycemia) usually the lowest blood glucose values were 3-4 (units were unknown).Her heart was not good, she would get anxious and angry, had hypertension and hypotension, had hyperglycemia, constipation, could not sleep, and legs were not good.The events of hypoglycemia and fall were considered serious by the company due to their medically significant reason.The information regarding the corrective treatment and outcome of the events were unknown.The status of insulin lispro protamine suspension 50%/insulin lispro 50%treatment was continued.Follow up was not possible as the patient was unwilling to provide more information and treating physician contact details could not be obtained.The user of the humapen ergo ii was unknown and her/his training status was not provided.The humapen ergo ii model duration of use was not provided.The action taken with the suspect humapen ergo ii and was unknown.It did not return to manufacturer.The initial reporting consumer did not know if the events were related with insulin lispro protamine suspension 50%insulin lispro 50% drug.The reporting consumer considered that the event of incorrect dose administered was due to product complaint issue of humapen ergo ii and did not report any relatedness for remaining events with humapen ergo ii.Edit 09feb2024: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 21feb2024: additional information received on 20feb2024 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields, return status to not returned to manufacturer for the suspect device associated with pc (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 21feb2024 in the b.5.Field.No further follow-up is planned.Evaluation summary: a female patient reported that her humapen ergo ii device was leaking fluid and the injection was not accurate.The patient experienced hypoglycemia.The device was not returned to the manufacturer for investigation (batch number unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.The patient subsequently reported that after changing the needle, the pen could be used, indicating that the problem was not a device manufacturing issue.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.

• 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): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer Contact: catherine cassidy ; lilly corporate center; indianapolis, IN 46285 ; 3174332191
• MDR Report Key: 18723009
• MDR Text Key: 335697610
• Report Number: 1819470-2024-00006
• 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: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Sex: Female