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

Model Number MS9557

Device Problems Use of Device Problem (1670); Failure to Deliver (2338); Infusion or Flow Problem (2964); Mechanical Jam (2983)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Manufacturer Narrative

Device not returned.Usage concerns resolved, and device was reported to be working properly.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 complaints (pc), concerned a (b)(6) male patient of han nationality.Medical history was not provided.Concomitant medication included melilotus officinalis extract, gliclazide and metformin, all for unknown indication.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100u/ml) from cartridges via reusable pen (humapen ergo ii), 14 units twice a day (each morning and evening), for treatment of diabetes mellitus beginning on mar-2017.On (b)(6) 2017, around three months after starting human insulin isophane suspension 70%/human insulin 30% therapy, the injection button of the humapen ergo ii could not be pushed down ((b)(4)/ lot number 1506d03).So, he did not inject his dose of human insulin isophane suspension 70%/human insulin 30%.He took melilotus officinalis extract, gliclazide and metformin by himself.On an unknown date, he had unstable blood glucose, poor eyesight and fundus haemorrhage (bleeding at the bottom of the eye) due to complication of diabetes mellitus.The humapen ergo ii had the situation that the injection button could not be pressed and could not get liquid medicine ((b)(4)/ lot number 1506d03).As of (b)(6) 2020, he was on hospitalization due to unstable blood glucose, poor eyesight and fundus haemorrhage.The event of complication of diabetes mellitus was considered serious due to its medical significance.Information regarding corrective treatment, outcome for the events and status of human insulin isophane suspension 70%/human insulin 30% therapy was not provided.The patient was the operator of the suspect humapen ergo ii devices (it was considered as improper use of device as the operator had visual impairment) and his training status was not provided.The humapen ergo ii devices model duration of use was not provided.The first suspect humapen ergo ii device duration of use was 13 months as it was started in (b)(6) 2016.The second suspect humapen ergo ii device duration of use was not provided.The use of the first suspect humapen ergo ii device was discontinued and its return status was not provided.The use of the second suspect humapen ergo ii device was continued as the usage concern was resolved and its return was not expected.The reporting consumer did not know if the event of missed dose was related to human insulin isophane suspension 70%/human insulin 30% and did not provide a relatedness assessment for the remaining events to human insulin isophane suspension 70%/human insulin 30% therapy.The reporting consumer related the event of missed dose to the first humapen ergo ii device issue and did not provide a relatedness assessment for remaining events to both humapen ergo ii devices.Update 28-jun-2017: this case was determined to be non-valid as there was no identifiable adverse event.Edit 02-aug-2017: upon review of the information, added a concomitant device to process the product complain received.The pc number received was (b)(4) and was processed.No other changes were made to the case.Update 08-sep-2020: this case was initially determined to be non-valid due to no identifiable valid adverse event.Additional information was received from initial reporter on 03-sep-2020, which contained a valid event.This case was upgraded to serious due to addition of serious events of unstable blood glucose, poor eyesight, fundus haemorrhage and complication of diabetes mellitus.Added second suspect device, laboratory data and concomitant medications.Upon review of the case, added event of missed dose and updated the first humapen ergo ii to suspect.Updated the narrative with accordingly.Edit 10sep2020: updated medwatch and european and (b)(6) fields for expedited device reporting.No new information added.

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 22sep2020 in the b.5.Field.No further follow-up is planned.Evaluation summary: a male patient reported that the injection button of his humapen ergo ii "could not be pressed and could not get liquid medicine." the patient experienced abnormal blood glucose.The device was not returned to the manufacturer for investigation (batch 1506d03, manufactured june 2015).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.However, during the conversation with the patient, the patient stated that the injection pen's malfunction had been self-corrected and there was no issue.A complaint history review of the batch did not identify any atypical findings with respect to 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 and dose accuracy with high probability.The patient reported visual impairment.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 complaint or event of abnormal blood glucose.

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 complaints (pc), concerned a 57-years-old male patient of han nationality.Medical history was not provided.Concomitant medication included melilotus officinalis extract, gliclazide and metformin, all for unknown indication.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100u/ml) from cartridges via reusable pen (humapen ergo ii), 14 units twice a day (each morning and evening), for treatment of diabetes mellitus beginning on (b)(6) 2017.On (b)(6) 2017, around three months after starting human insulin isophane suspension 70%/human insulin 30% therapy, the injection button of the humapen ergo ii could not be pushed down ((b)(4)/ lot number 1506d03).So, he did not inject his dose of human insulin isophane suspension 70%/human insulin 30%.He took melilotus officinalis extract, gliclazide and metformin by himself.On an unknown date, he had unstable blood glucose, poor eyesight and fundus haemorrhage (bleeding at the bottom of the eye) due to complication of diabetes mellitus.The humapen ergo ii had the situation that the injection button could not be pressed and could not get liquid medicine ((b)(4)/ lot number 1506d03).As of (b)(6) 2020, he was on hospitalization due to unstable blood glucose, poor eyesight and fundus haemorrhage.The event of complication of diabetes mellitus was considered serious due to its medical significance.Information regarding corrective treatment, outcome for the events and status of human insulin isophane suspension 70%/human insulin 30% therapy was not provided.The patient was the operator of the suspect humapen ergo ii devices (it was considered as improper use of device as the operator had visual impairment) and his training status was not provided.The humapen ergo ii devices model duration of use was not provided.The first suspect humapen ergo ii device duration of use was 13 months as it was started in (b)(6) 2016.The second suspect humapen ergo ii device duration of use was not provided.The use of the first suspect humapen ergo ii device was discontinued and its return status was not provided.The use of the second suspect humapen ergo ii device was continued as the usage concern was resolved.The second suspect humapen ergo ii device (lot 1506d03) associated with product complaint (b)(4) was not returned to the manufacturer(reportedly this device had self corrected and there was no issue).The reporting consumer did not know if the event of missed dose was related to human insulin isophane suspension 70%/human insulin 30% and did not provide a relatedness assessment for the remaining events to human insulin isophane suspension 70%/human insulin 30% therapy.The reporting consumer related the event of missed dose to the first humapen ergo ii device issue and did not provide a relatedness assessment for remaining events to both humapen ergo ii devices.Update 28-jun-2017: this case was determined to be non-valid as there was no identifiable adverse event.Edit 02-aug-2017: upon review of the information, added a concomitant device to process the product complain received.The pc number received was (b)(4) and was processed.No other changes were made to the case.Update 08-sep-2020: this case was initially determined to be non-valid due to no identifiable valid adverse event.Additional information was received from initial reporter on (b)(6) 2020, which contained a valid event.This case was upgraded to serious due to addition of serious events of unstable blood glucose, poor eyesight, fundus haemorrhage and complication of diabetes mellitus.Added second suspect device, laboratory data and concomitant medications.Upon review of the case, added event of missed dose and updated the first humapen ergo ii to suspect.Updated the narrative with accordingly.Edit 10sep2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 22sep2020: additional information received on 22sep2020 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, changed malfunction from unknown to no and added date of manufacturer for the second suspect humapen ergo ii device (lot 1506d03) associated with product complaint (b)(4), which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.Update 23sep2020: additional information received on 22sep2020 from the global product complaint database.No new information added.

• 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: 10546391
• MDR Text Key: 207324555
• Report Number: 1819470-2020-00116
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• 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: 1506D03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 57 YR
• Patient Weight: 60