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

Model Number MS9557

Device Problems Material Too Rigid or Stiff (1544); Use of Device Problem (1670); Improper Flow or Infusion (2954); Mechanical Jam (2983); Patient Device Interaction Problem (4001)

Patient Problems Hyperglycemia (1905); Localized Skin Lesion (4542)

Event Date 01/31/2020

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

(b)(4).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) year-old (at the time of initial report) female patient with unknown an origin.Medical history included diabetes since she was (b)(6) years-old.Concomitant medications were not provided.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30), from cartridge via a reusable device humapen ergo ii, 40 international units in the morning and 28 international units in the evening; twice daily, subcutaneously, for the treatment of type 1 diabetes mellitus, beginning on an unknown date (reported as more than 30 years).She was using humapen ergo ii application pen since (b)(6) 2019.Since (b)(6) 2020, some application pen had problems in short time, but some were functioning for a long time which lasted the application pen used for a long time.The ball of the application pen was not pressed due to its hardness and it was not moving.The ball was not like that when the application pen was new.She felt tired when she was trying to receive insulin with pushing the ball.The piston was hardened and she had trouble with needle tip since it caused pain due to excessive force.The insulin did not receive quickly and she pushed the application pen and it caused pain (batch number: 1502d01 and product complaint number: (b)(4)).Since an unknown date in 2020, while on human insulin isophane suspension 70%/human insulin 30%, she itched which converted into wound due to diabetes/high blood sugar (value, unit and reference range not provided) due to which she was hospitalized on (b)(6) 2020 and discharged after one week.Information regarding further hospitalization details and corrective treatment was not provided.Outcome of the events diabetic wound and high blood sugar was resolving while that of remaining events was not provided.The status of human insulin isophane suspension 70%/human insulin 30% therapy was not provided.Follow up was not possible since the reporter did not give consent herself and her doctors for follow up procedures.The patient was the operator of humapen ergo ii and her training status was not provided.The general humapen ergo ii duration and suspect humapen ergo ii duration was not provided however it was started in (b)(6) 2019.Action taken with humapen ergo ii and its return status was were not provided.The initial reporting consumer did not provide the relatedness assessment of the events with human insulin isophane suspension 70%/human insulin 30% therapy and humapen ergo ii.Update 05-apr-2021: information was received on 31-mar-2021 from the responsible contact person (rcp) provided the product complaint (pc) reference number (b)(4)).No medically significant information was added.No further changes were done to the case.Edit 20apr2021: 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 solicited case, reported by a consumer via a patient support program (psp), concerned a 48-year-old (at the time of initial report) female patient with unknown an origin.Medical history included diabetes since she was 5-years-old.Concomitant medications were not provided.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30), from cartridge via a reusable device humapen ergo ii, 40 international units in the morning and 28 international units in the evening; twice daily, subcutaneously, for the treatment of type 1 diabetes mellitus, beginning on an unknown date (reported as more than 30 years).She was using humapen ergo ii application pen since (b)(6) 2019.Since (b)(6) 2020, some application pen had problems in short time, but some were functioning for a long time which lasted the application pen used for a long time.The ball of the application pen was not pressed due to its hardness and it was not moving.The ball was not like that when the application pen was new.She felt tired when she was trying to receive insulin with pushing the ball.The piston was hardened and she had trouble with needle tip since it caused pain due to excessive force.The insulin did not receive quickly and she pushed the application pen and it caused pain (batch number: 1502d01 and product complaint number: (b)(4)).Since an unknown date in 2020, while on human insulin isophane suspension 70%/human insulin 30%, she itched which converted into wound due to diabetes/high blood sugar (value, unit and reference range not provided) due to which she was hospitalized on (b)(6) 2020 and discharged after one week.Information regarding further hospitalization details and corrective treatment was not provided.Outcome of the events diabetic wound and high blood sugar was resolving while that of remaining events was not provided.The status of human insulin isophane suspension 70%/human insulin 30% therapy was not provided.Follow up was not possible since the reporter did not give consent herself and her doctors for follow up procedures.The patient was the operator of humapen ergo ii and her training status was not provided.The general humapen ergo ii duration and suspect humapen ergo ii duration was not provided however it was started in (b)(6) 2019.The suspect humapen ergo ii, was manufactured in (b)(6) 2021, and was not returned to the manufacturer.The initial reporting consumer did not provide the relatedness assessment of the events with human insulin isophane suspension 70%/human insulin 30% therapy and humapen ergo ii.Update (b)(6) 2021: information was received on (b)(6) 2021 from the responsible contact person (rcp) provided the product complaint (pc) reference number (b)(4)).No medically significant information was added.No further changes were done to the case.Edit 20apr2021: updated medwatch fields for expedited device reporting.No new information added.Update 05may2021: additional information received on 05may2021 from the global product complaint database.Entered device specific safety summary (dsss).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 pc(b)(4)associated with unknown lot of humapen ergo ii 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 05may2021 in the b.5.Field.No further follow-up is planned.Evaluation summary a female patient reported that the "ball" of her humapen ergo ii device "was not pressed due to its hardness and it was not moving." she reported "the piston was hardened" and she "had trouble with needle tip since it caused pain due to excessive force." the patient experienced increased blood glucose and diabetic wound.The device was not returned to the manufacturer for investigation (batch 1502d01, manufactured february 2015).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 dose accuracy and high injection force issues, and the batch threshold review did not identify any atypical findings with regard to dose accuracy issues.Also, the total number of complaints received for batch 1502d01 is within the established batch threshold, and the batch is not atypical.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.

• Brand Name: HUMAPEN ERGO II
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 11713618
• MDR Text Key: 262520064
• Report Number: 1819470-2021-00051
• 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,Followup
• Report Date: 05/26/2021

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: 1502D01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/23/2021
• Supplement Dates Manufacturer Received: 05/05/2021
• Supplement Dates FDA Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 47 YR