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

Model Number MS9557

Device Problems Mechanical Problem (1384); Use of Device Problem (1670); Mechanical Jam (2983)

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 consumer via patient support program (psp), concerned a male patient of unknown age and origin.Medical history, previous drug adverse reaction, family drug reaction were not provided.Concomitant medication was none.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100u/ml) from cartridge via reusable device (humapen ergo ii), 25units twice daily (morning and evening), subcutaneously, for the treatment of diabetes mellitus from an unknown date.On an unknown date while on human insulin isophane suspension 70%/human insulin 30% therapy, he had hyperglycaemia (value of high blood glucose and reference ranges were provided) which required hospitalisation.He was discharged (the time for hospitalization and the time for discharging was unknown).Reportedly in (b)(6) 2020, his humapen ergo ii was fallen off and was not as smooth as before (b)(4)/ lot number 1502d02).It was especially tight when pushing insulin out and was very not good to use (the injection button was difficult to be pushed down).He changed the needle once in every one or two days (improper use of device).Information regarding corrective treatment and outcome for the event was not provided.Human insulin isophane suspension 70%/human insulin 30% therapy was ongoing.The patient was the operator of the humapen ergo ii and his training status was not provided.The humapen ergo ii model duration of use was not provided.The suspect humapen ergo ii duration of use was three years as it was started in 2017.The use of the suspect humapen ergo ii was ongoing and its return status was not provided.The reporting consumer did not provide a relatedness assessment between the event and human insulin isophane suspension 70%/human insulin 30% therapy or the humapen ergo ii.Edit 24aug2020: updated medwatch and (b)(6) 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 consumer via patient support program (psp), concerned a male patient of unknown age and origin.Medical history, previous drug adverse reaction, family drug reaction were not provided.Concomitant medication was none.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100u/ml) from cartridge via reusable device (humapen ergo ii), 25units twice daily (morning and evening), subcutaneously, for the treatment of diabetes mellitus from an unknown date.On an unknown date while on human insulin isophane suspension 70%/human insulin 30% therapy, he had hyperglycaemia (value of high blood glucose and reference ranges were provided) which required hospitalisation.He was discharged (the time for hospitalization and the time for discharging was unknown).Reportedly in (b)(6) 2020, his humapen ergo ii was fallen off and was not as smooth as before ((b)(4) / lot number 1502d02).It was especially tight when pushing insulin out and was very not good to use (the injection button was difficult to be pushed down).He changed the needle once in every one or two days (improper use of device).Information regarding corrective treatment and outcome for the event was not provided.Human insulin isophane suspension 70%/human insulin 30% therapy was ongoing.The patient was the operator of the humapen ergo ii and his training status was not provided.The humapen ergo ii model duration of use was not provided.The suspect humapen ergo ii duration of use was three years as it was started in 2017.The use of the suspect humapen ergo ii was ongoing and the device was returned to the manufacturer on 31aug2020.The reporting consumer did not provide a relatedness assessment between the event and human insulin isophane suspension 70%/human insulin 30% therapy or the humapen ergo ii.Edit 24aug2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.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, malfunction from unknown to no, and device return status to returned to manufacturer; and added the date of manufacture and date returned to manufacturer for the suspect device associated with (b)(4).Corresponding fields and narrative updated accordingly.Edit 30sep2020: corrected narrative; added date device was returned to the manufacturer.

Manufacturer Narrative

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 male patient reported that that the injection button of his humapen ergo ii device was not as smooth as before and was difficult to push down.He experienced hyperglycemia.The investigation of the returned device (batch 1502d02, manufactured february 2015) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.The patient reported that he changed the needle once in every one or two days.The core instructions for use states 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 hyperglycemia.

• Brand Name: HUMAPEN ERGO II
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis, in
• MDR Report Key: 10459806
• MDR Text Key: 204694323
• Report Number: 1819470-2020-00112
• 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: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• 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: 1502D02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization