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

Model Number MS9557

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

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 history included type i diabetes mellitus.Concomitant medication was not reported.The patient received insulin lispro (rdna origin) injection (humalog, 100u/ml) from cartridge via reusable pen humapen ergo ii, for the treatment of unknown indication, beginning on an unknown date in 2015.Dose, route and frequency were not provided.She was using humapen ergo ii since 2021.On an unknown date in (b)(6) 2023, while on insulin lispro therapy, the plunger of the humapen ergo ii was broken due to which she was not receiving the insulin lispro dose (pc number: (b)(4) and lot number: d272981).Due to not receiving insulin lispro, her diabetes was out of control and her blood glucose reached to 400 (units and reference range was not provided) and also experienced ketoacidosis.On (b)(6) 2023 (as reported), she was not seeing properly and had stroke in the eye due to high blood glucose level and surgery would be required.Moreover, she was the operator of device (improper use).She had bad glycosylated hemoglobin (value, unit and reference range not provided) and had a pending surgery.The event of ketoacidosis was considered as serious by the company due to its medical significance.The information regarding the outcome of events, corrective treatment details and status of insulin lispro therapy was not provided.The operator of the humapen ergo ii device was patient and her training status was not provided.The device model duration of use was not provided and the suspect device duration of use was two years.The action taken with the suspect device was not provided and its return was not expected.The initial reporting consumer did not provide the relatedness assessment of the events with the insulin lispro therapy.The reporting consumer did not provide the relatedness assessment of the event glycosylated hemoglobin increased with humapen ergo ii while related the remaining events with the humapen ergo ii.Update 04-sep-2023: additional information was received from the initial reporting consumer on 28-aug-2023.Added one lab data and two non-serious events of missed dose and glycosylated hemoglobin increased.Updated narrative with new information.Edit 06-sep-2023: upon review, follow up receipt date was updated in narrative from 29-aug-2023 to 28-aug-2023.No other changes were made to the case.Edit 12 sep 2023: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 14-sep-2023: upon review of information received on 28-aug-2023, the operator of device was updated to patient and improper use field updated from no to yes.Updated narrative accordingly.

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)(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 history included type i diabetes mellitus.Concomitant medication was not reported.The patient received insulin lispro (rdna origin) injection (humalog, 100u/ml) from cartridge via reusable pen humapen ergo ii, for the treatment of unknown indication, beginning on an unknown date in 2015.Dose, route and frequency were not provided.She was using humapen ergo ii since 2021.On an unknown date in (b)(6) 2023, while on insulin lispro therapy, the plunger of the humapen ergo ii was broken due to which she was not receiving the insulin lispro dose (pc number: (b)(4) and lot number: 2001d04).Due to not receiving insulin lispro, her diabetes was out of control and her blood glucose reached to 400 (units and reference range was not provided) and also experienced ketoacidosis.On (b)(6) 2023 (as reported), she was not seeing properly and had stroke in the eye due to high blood glucose level and surgery would be required.Moreover, she was the operator of device (improper use).She had bad glycosylated hemoglobin (value, unit and reference range not provided) and had a pending surgery.The event of ketoacidosis was considered as serious by the company due to its medical significance.The information regarding the outcome of events, corrective treatment details and status of insulin lispro therapy was not provided.The operator of the humapen ergo ii device was patient and her training status was not provided.The device model duration of use was not provided and the suspect device duration of use was two years.The action taken with the suspect device was not provided and the device was not returned to the manufacturer for investigation.The initial reporting consumer did not provide the relatedness assessment of the events with the insulin lispro therapy.The reporting consumer did not provide the relatedness assessment of the event glycosylated hemoglobin increased with humapen ergo ii while related the remaining events with the humapen ergo ii.Update 04-sep-2023: additional information was received from the initial reporting consumer on 28-aug-2023.Added one lab data and two non-serious events of missed dose and glycosylated hemoglobin increased.Updated narrative with new information.Edit 06-sep-2023: upon review, follow up receipt date was updated in narrative from 29-aug-2023 to 28-aug-2023.No other changes were made to the case.Edit 12sep2023: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 14-sep-2023: upon review of information received on 28-aug-2023, the operator of device was updated to patient and improper use field updated from no to yes.Updated narrative accordingly.Update 02oct2023: additional information received on 25sep2023 from the global product complaint database.Changed the lot number on humapen ergo ii from d272981 to 2001d04 for product complaint (b)(4) (as d272981 is a packaging batch number associated with actual device batch number is 2001d04).Entered device specific safety summary (dsss) for humapen ergo ii device associated with pc (b)(4) and lot 2001d04.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.Edit 02oct2023: the case was unlocked to amend the follow-up receipt date as 25sep2023 in the update statement dated 02oct2023 of case narrative.

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 02oct2023 in the b.5.Field.No further follow-up is planned.Evaluation summary: a female patient reported that the plunger of her humapen ergo ii device was broken/not moving when attempting to inject; therefore, she was not receiving the insulin lispro dose.The patient experienced ketoacidosis.The device was not returned to the manufacturer for investigation (batch number 2001d04, manufactured january 2020).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review did not identify any atypical findings with regard to injection screw/ratchet not moving issues.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.The humapen ergo ii core instructions for use states to always carry a spare insulin pen in case your pen is lost or damaged.The patient reported she was not seeing properly.The core instructions for use state that the device is not recommended for the visually impaired without the assistance of a sighted individual trained to use it.There is evidence of improper use.The patient used the device while visually impaired.It is unknown if this misuse is relevant to the event of ketoacidosis.

• 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: 17766545
• MDR Text Key: 323692004
• Report Number: 1819470-2023-00061
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• 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: 2001D04
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2020
• 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