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

Model Number MS9557

Device Problems Inaccurate Delivery (2339); Audible Prompt/Feedback Problem (4020)

Patient Problem Arrhythmia (1721)

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 consumer who contacted the company to report adverse events and product complaint (pc), concerned a female patient of unknown age and origin.Medical history (complication, allergy history, family history), previous drug adverse reaction, family drug reaction and concomitant medication were not provided.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog mix50, 100u/ml) from cartridge via reusable pen (humapen ergo ii), for the treatment of diabetes mellitus, beginning on an unknown date.Dosage regimen was not provided.On an unknown date in (b)(6) 2020 or (b)(6) 2020, after starting insulin lispro protamine suspension 50%/insulin lispro 50% therapy, there was an issue with the humapen ergo ii that it used to click per unit and now there was one click every two units (pc 5283673/ lot number 1406d01).Thus, she received inaccurate dosage of insulin lispro protamine suspension 50%/insulin lispro 50%.She had situation of chest distress or tightness and arrhythmia on the body due to due to inaccurate dosage.The event of arrhythmia was considered serious due to its medical significance.Chest distress or tightness was considered as symptom associated with the diagnosis of arrhythmia.Information regarding corrective treatment was not provided.She did not recover from the events.Insulin lispro protamine suspension 50%/insulin lispro 50% therapy was ongoing.Follow up was not possible as the reporter refused to be followed up via phone and physician contact details were not provided.The operator of the humapen ergo ii and his/her training status were not provided.The humapen ergo ii model duration of use was not provided.The suspect humapen ergo ii device duration of use was approximately 42 months (three to four years) as it was started in 2016 or 2017.The use of the suspect humapen ergo ii was ongoing and its return status was not provided.The reporting consumer did not know if the events were related to insulin lispro protamine suspension 50%/insulin lispro 50%.The reporting consumer related the events to humapen ergo ii device issue.Edit 16sep2020: updated medwatch fields for expedited device reporting and added contact log accordingly.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 consumer who contacted the company to report adverse events and product complaint (pc), concerned a female patient of unknown age and origin.Medical history (complication, allergy history, family history), previous drug adverse reaction, family drug reaction and concomitant medication were not provided.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog mix50, 100u/ml) from cartridge via reusable pen (humapen ergo ii), for the treatment of diabetes mellitus, beginning on an unknown date.Dosage regimen was not provided.On an unknown date in (b)(6)2020, after starting insulin lispro protamine suspension 50%/insulin lispro 50% therapy, there was an issue with the humapen ergo ii that it used to click per unit and now there was one click every two units ((b)(4)/ lot number 1406d01).Thus, she received inaccurate dosage of insulin lispro protamine suspension 50%/insulin lispro 50%.She had situation of chest distress or tightness and arrhythmia on the body due to due to inaccurate dosage.The event of arrhythmia was considered serious due to its medical significance.Chest distress or tightness was considered as symptom associated with the diagnosis of arrhythmia.Information regarding corrective treatment was not provided.She did not recover from the events.Insulin lispro protamine suspension 50%/insulin lispro 50% therapy was ongoing.Follow up was not possible as the reporter refused to be followed up via phone and physician contact details were not provided.The operator of the humapen ergo ii and his/her training status were not provided.The humapen ergo ii model duration of use was not provided.The suspect humapen ergo ii device duration of use was approximately 42 months (three to four years) as it was started in 2016 or 2017.The use of the suspect humapen ergo ii was ongoing and it was not returned to the manufacturer.The reporting consumer did not know if the events were related to insulin lispro protamine suspension 50%/insulin lispro 50%.The reporting consumer related the events to humapen ergo ii device issue.Edit 16sep2020: updated medwatch fields for expedited device reporting and added contact log accordingly.No new information added.Update 30sep2020: additional information received on 28sep2020 and 29sep2020 from the global product complaint database, which were processed together.Entered the device specific safety summary (dsss).Updated the medwatch and european and canadian (eu/ca) device fields.Added the date of manufacture for the suspect device associated with (b)(4).Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

If device is returned, evaluation will be performed to determine if a malfunction has occurred.B.5.Narrative field; new updated and corrected information is referenced within the update statements in b.5.Please refer to statement dated 30sep2020 in the b.5.Field.No further follow up is planned.Evaluation summary: a female patient reported that her humapen ergo ii device used to click per unit and now there was one click every two units.Thus, she alleged that she received inaccurate dosage.The patient experienced arrhythmia.The device was not returned to the manufacturer for investigation (batch 1406d01, manufactured june 2014).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.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 using the device approximately 42 months (three to four years) as it was started in 2016 or 2017.The core instructions for use states the humapen ergo ii has been designed to be used for up to three years after first use.In addition, the patient reportedly continued to use the device.The core instructions for use state if any of the parts of your humapen ergo ii appear broken or damaged, do not use.There is evidence of improper use.The patient used the device beyond its approved use life and continued to use the device after experiencing the alleged complaint issue.It is unlikely these use issues are relevant to the event of arrhythmia.

• 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: 10567799
• MDR Text Key: 207965111
• Report Number: 1819470-2020-00123
• 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: 09/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1406D01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other