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

Model Number MS9557

Device Problems Mechanical Problem (1384); Failure to Deliver (2338); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Hyperglycemia (1905)

Event Date 01/31/2021

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 product complaint, concerned a 72-year-old male patient of han nationality.Medical history was not provided.The concomitant medication included liraglutide for an unknown indication.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) through a cartridge, via a reusable pen (humapen ergo ii), 18 units morning and 14 units at night, twice daily, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date in 2015.On an unknown date in 2019 after starting insulin lispro protamine suspension 75%/insulin lispro 25%, he was hospitalized for one week due to diabetic complications.On an unknown date in 2021, he was hospitalized due to blood glucose fluctuations and poor vision and because the insulin was not injected in, he took metformin orally on his own.On an unknown date in (b)(6) 2022, he went halfway through the injection, the humapen ergo ii could be depressed directly to the end without clicking sound and insulin was not injected in the body (pc number - 6034261, batch- 1601d03).On an unknown date, his fasting blood glucose was 13.7 due to the injection pen issue.Information regarding corrective treatment and outcome of the events was not provided.The insulin lispro protamine suspension 75%/insulin lispro 25% was continued.The operator of the humapen ergo-ii and his/her training status was not provided.The humapen ergo-ii general and suspect device duration of use was approximately two years as was started in 2020.The action taken with the suspect humapen ergo-ii was unknown and its return was expected.The reporting consumer did not know if the events were related with insulin lispro protamine suspension 75%/insulin lispro 25% therapy and did not provide the relatedness of the events with humapen ergo-ii.Edit 12jul2022: updated medwatch and european and canadian (eu/ca) 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 events and product complaint, concerned a 72-year-old male patient of han nationality.Medical history was not provided.The concomitant medication included liraglutide for an unknown indication.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) through a cartridge, via a reusable pen (humapen ergo ii), 18 units morning and 14 units at night, twice daily, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date in 2015.On an unknown date in 2019 after starting insulin lispro protamine suspension 75%/insulin lispro 25%, he was hospitalized for one week due to diabetic complications.On an unknown date in 2021, he was hospitalized due to blood glucose fluctuations and poor vision and because the insulin was not injected in, he took metformin orally on his own.On an unknown date in (b)(6) 2022, he went halfway through the injection, the humapen ergo ii could be depressed directly to the end without clicking sound and insulin was not injected in the body (pc number - (b)(4), batch- 1601d03).On an unknown date, his fasting blood glucose was 13.7 due to the injection pen issue.Information regarding corrective treatment and outcome of the events was not provided.The insulin lispro protamine suspension 75%/insulin lispro 25% was continued.The operator of the humapen ergo-ii and his/her training status was not provided.The humapen ergo-ii general and suspect device duration of use was approximately two years as was started in 2020.The action taken with the suspect humapen ergo-ii was unknown and the device was returned to manufacturer.The reporting consumer did not know if the events were related with insulin lispro protamine suspension 75%/insulin lispro 25% therapy and did not provide the relatedness of the events with humapen ergo-ii.Edit 12jul2022: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 28jul2022: additional information received on 26jul2022 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information for (b)(4) associated with lot number 1601d03 of humapen ergo ii.Updated improper use and storage from no to yes, malfunction from unknown to no, date of manufacturer, device return status to returned to manufacturer, and date returned to manufacturer for the device.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 28jul2022 in the b.5.Field.No further follow-up is planned.Evaluation summary: a male patient reported that on an unknown date in (b)(6) 2022, he went halfway through the injection using his humapen ergo ii, and the pen could be depressed directly to the end without clicking sound and insulin was not injected in the body.On an unknown date in 2021, he experienced blood glucose fluctuation.The investigation of the returned device (batch 1601d03, manufactured january 2016) found the front housing threads were slightly broken, there was a crack on the pen body, and the soft touch was partly de-bonded, with evidence of excessive force observed for all issues.However, the device met functional requirements and met dose accuracy and glide (injection) force specifications.The core instructions for use states to always carry a spare insulin pen in case your pen is lost or damaged.There is evidence of improper use.The damage to the device is consistent with damage while in the field.This misuse is not likely relevant to the event of blood glucose fluctuation since the device met functional requirements and met dose accuracy and glide (injection) force specifications.

• 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: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 15014090
• MDR Text Key: 295900700
• Report Number: 1819470-2022-00051
• 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: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1601D03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2016
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian