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

Model Number MS9557

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Deliver (2338)

Patient Problem Hyperglycemia (1905)

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 solicited case, reported by two consumer reporters via a patient support program (psp), concerned a (b)(6) years-old female patient of unknown origin.Medical history included and concomitant medications were not provided.The patient received human insulin (rdna origin) regular (humulin r) from a cartridge, via a reusable pen device (humapen ergo ii), at 20 international units (iu), three times daily, subcutaneously, for the treatment of diabetes, beginning sometime in 2012.She started using unknown his current humapen ergo ii approximately sometime in (b)(6) 2019 (reported as one year and two to four months ago).She had been using unknown devices in past.Sometime in (b)(6) 2020 (from four weeks), while on human insulin treatment, her humapen ergo ii got impaired (pc number: (b)(4) and lot number: 1710d04) as when she adjusted the dose on 30 iu and pushed the injection button, it did not release any insulin, after which her physician gave her another grey (as reported) insulin pen to be taken once at night but she did not know the name of the insulin.On an unknown date, she started to suffer from persistent high glucose blood level (values, units and normal reference range not provided) and from sudden persistent leg swelling that was not decreased; due to both which she underwent an amputation surgery on her toe from eight months, sometime in (b)(6) 2020 for which she was hospitalized for three days.She exchanged the needle with every cartridge (every week), was considered to be improper use.Information regarding additional corrective treatment, hospitalization dates and outcome for events was not provided.Human insulin treatment was continued.The patient was the operator of the humapen ergo ii and her training status was not provided.The general humapen ergo ii model duration of use was approximately sixteen months and the suspect humapen ergo ii model duration of use was not provided.The action taken with the suspect humapen ergo ii and its return status was not provided.No troubleshooting was done.The reporting consumers did not provide any relatedness for the event with human insulin treatment and humapen ergo ii.Update 12-jan-2021: this case was determined to be non-valid as there was no identifiable valid event however patient had toe amputation (reason unspecified).Update 16-feb-2021: additional information received from the initial reporter in response to the follow-up attempt on 14-feb-2021 via psp.This case became valid per addition of serious events of high blood glucose and persistent leg swelling with hospitalization criteria.Added; laboratory tests for blood glucose.Removed event of toe amputation.Updated; humapen ergo ii device type to suspect, causality statement and narrative with new information.Edit 18feb2021: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.Edit 18-feb-2021: upon review of information received on 14-feb-2021, outcome for events was updated to unknown (previously: recovered) and improper use was added to case device field and in narrative.No other changes were made.

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 26feb2021 in the b.5.Field.No further follow-up is planned.Evaluation summary: a female patient reported that in (b)(6) 2020 her humapen ergo ii did not release any insulin.On an unknown date, the patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch 1710d04, manufactured october 2017).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review and a batch trend review did not identify any atypical findings with regard to device not working or dose accuracy 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 patient reported that she changed insulin needle with every cartridge (every week).The core instructions for use state to use a new needle for each injection.There is evidence of improper use.The patient reused needles.This misuse may be relevant to the complaint and the event of increased blood glucose.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited case, reported by two consumer reporters via a patient support program (psp), concerned a 51-years-old female patient of unknown origin.Medical history included and concomitant medications were not provided.The patient received human insulin (rdna origin) regular (humulin r) from a cartridge, via a reusable pen device (humapen ergo ii), at 20 international units (iu), three times daily, subcutaneously, for the treatment of diabetes, beginning sometime in 2012.She started using unknown his current humapen ergo ii approximately sometime in (b)(6) 2019 (reported as one year and two to four months ago).She had been using unknown devices in past.Sometime in (b)(6) 2020 (from four weeks), while on human insulin treatment, her humapen ergo ii got impaired (pc number: (b)(4) and lot number: 1710d04) as when she adjusted the dose on 30 iu and pushed the injection button, it did not release any insulin, after which her physician gave her another grey (as reported) insulin pen to be taken once at night but she did not know the name of the insulin.On an unknown date, she started to suffer from persistent high glucose blood level (values, units and normal reference range not provided) and from sudden persistent leg swelling that was not decreased; due to both which she underwent an amputation surgery on her toe from eight months, sometime in (b)(6) 2020 for which she was hospitalized for three days.She exchanged the needle with every cartridge (every week), was considered to be improper use.Information regarding additional corrective treatment, hospitalization dates and outcome for events was not provided.Human insulin treatment was continued.The patient was the operator of the humapen ergo ii and her training status was not provided.The general humapen ergo ii model duration of use was approximately sixteen months and the suspect humapen ergo ii model duration of use was not provided.The suspect humapen ergo ii device associated with (b)(4) was not returned to the manufacturer.The reporting consumers did not provide any relatedness for the event with human insulin treatment and humapen ergo ii.Update 12-jan-2021: this case was determined to be non-valid as there was no identifiable valid event however patient had toe amputation (reason unspecified).Update 16-feb-2021: additional information received from the initial reporter in response to the follow-up attempt on 14-feb-2021 via psp.This case became valid per addition of serious events of high blood glucose and persistent leg swelling with hospitalization criteria.Added; laboratory tests for blood glucose.Removed event of toe amputation.Updated; humapen ergo ii device type to suspect, causality statement and narrative with new information.Edit 18feb2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 18-feb-2021: upon review of information received on 14-feb-2021, outcome for events was updated to unknown (previously: recovered) and improper use was added to case device field and in narrative.No other changes were made.Update 26feb2021: additional information received on 26feb2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information.Added date of manufacturer for the suspect humapen ergo ii device associated with product complaint (b)(4), which was not returned to the manufacturer.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
• MDR Report Key: 11358996
• MDR Text Key: 242037112
• Report Number: 1819470-2021-00032
• 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: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• 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: 1710D04
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 51 YR