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)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Manufacturer Narrative

No further follow-up is planned.This report is associated with mdr 1819470-2019-00187 since there is more than one device implicated.Evaluation summary: a male patient reported that the injection button of his humapen ergo ii device "had no injection force, it was pressed down to the end at once without clicking sound and insulin could not be ejected out." the patient experienced increased blood glucose.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.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.There is no evidence of improper use or storage.

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), with additional information from the initial reporter, concerned a (b)(6)-year-old asian male patient (with nationality: (b)(6)).Medical history was not provided.Concomitant medication included metformin for unknown indication.The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) injection (humulin 70/30), cartridge via a reusable pen (humapen ergo ii, color blue) 12 units in the morning and 12 units at night (twice daily), subcutaneously for the treatment of diabetes mellitus type ii starting sometime between 2009 and 2011 (conflicting information).Approximately on (b)(6) 2019 the injection button of the humapen ergo ii was pushed down to the end directly without clicking sounds and so the insulin could not be pushed out and was not coming out of the humapen ergo ii (pc: (b)(4)/ lot: unknown).On unspecified dates, he had been in hospital for several times while taking human insulin isophane suspension 70%/ human insulin 30%.On an unspecified date, he ate and drank too much; therefore his blood glucose was high (no units or values provided) and consequently had to be hospitalized.Hospitalization dates were not provided.After the first injection pen was broken, injection button of the humapen had no injection force, it was pressed down to the end at once without clicking sound and insulin could not be ejected out (pc number: (b)(4)/ lot unknown).The replacement injection pen was lost again.He did not inject insulin from around (b)(6) 2021, the blood glucose was high, the temper was not very good.Information regarding corrective treatment and outcome of the events was not provided.Human insulin isophane suspension 70%/ human insulin 30% treatment status was unknown.The user of the humapen ergo ii was the patient and his training status was not provided.The general humapen ergo ii model duration of use was not provided, and the reported first suspect humapen ergo ii had been in use since an unspecified date in 2017.Additionally, reported second suspect humapen ergo ii had been in use since an unspecified date in 2018.The action taken for both humapen ergo ii was not provided and were not returned to the manufacturer.The reporting consumer did not provide an assessment of relatedness between serious event of blood glucose increased (first episode) and human insulin isophane suspension 70%/ human insulin 30% treatment while did not know about an assessment of relatedness between the remaining events and human insulin isophane suspension 70%/ human insulin 30% treatment.The reporting consumer did not provide an assessment of relatedness between events and humapen ergo ii device.Update 20-sep-2019: this case was considered non-valid due to no identifiable valid adverse event was reported, only hospitalization without further details.Update 27-sep-2019: this case was initially determined to be non-valid (hospitalization described only).Additional information received on 24-sep-2019 from the initial reporter in response to a follow-up that contained valid adverse event information and the reason for the hospitalization.Case was updated to valid.Added the serious event of blood glucose high and laboratory data.Updated indication of human insulin isophane suspension 70%/ human insulin 30% treatment from diabetes mellitus to diabetes mellitus type ii, and humapen ergo ii device from concomitant to suspect.The narrative and fields were updated accordingly.Update 03-oct-2019: information was received from the affiliate on 18-sep-2019.Tr number was received and pc was processed accordingly.No medically significant information was added to the case.Edit 04-oct-2019: upon review, it was entered the device age on the suspect device tab.No other changes performed or required.Edit 08oct2019: updated medwatch fields for expedited device reporting.No new information added.Update 10-oct-2019: additional information was received on 26-sep-2019 from affiliate.No medically significant information was received and no changes were made in the case.Update 29oct2019: additional information received on 28oct2019 and 29oct2019 from the global product complaint database which were processed together.Entered the device specific safety summary (dsss).Updated the medwatch and european and (b)(6) (eu/(b)(6)) device fields for the suspect device associated with pc (b)(4).Corresponding fields and narrative updated accordingly.Update 14-apr-2021: additional information received from the initial reporting consumer on 12-apr-2021.Added secondary consumer reporter.Added patient demographics (including age, eight, weight and race information).Added one lab test and two non-serious event of blood glucose and anger.Updated dosage regimen and action taken of human insulin isophane suspension 70%/ human insulin 30% therapy.Added an additional suspect humapen ergo ii and a concomitant medication.Updated narrative and causality statement with new information accordingly.Update 27apr2021: additional information received on 27apr2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and (b)(6) (eu/(b)(6)) device information, and device return status to not returned to manufacturer for pc (b)(4) associated with unknown lot of humapen ergo ii device.Corresponding fields and narrative updated accordingly.

• 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: chris davis ; lilly corporate center; indianapolis, IN 46285
• MDR Report Key: 11745012
• MDR Text Key: 264296342
• Report Number: 1819470-2021-00059
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 04/29/2021

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/12/2021
• Initial Date FDA Received: 04/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 53 YR
• Patient Weight: 71