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

Model Number MS9557

Device Problems Loose or Intermittent Connection (1371); Use of Device Problem (1670); Connection Problem (2900); Material Integrity Problem (2978); Priming Problem (4040)

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 a consumer via a patient support program (psp), concerned a (b)(6) years-old asian male patient.Medical history included high blood pressure, high blood lipid, high cholesterol and high triglyceride.Concomitant medication included metformin for the treatment of diabetes mellitus.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog 25) from cartridge via humapen ergo ii device, 28 units twice daily subcutaneously, for the treatment of type ii diabetes, beginning somewhere in 2019.On an unknown date in (b)(6) 2021, while on insulin lispro protamine suspension 75%/insulin lispro 25% therapy, he got hospitalized due to poor blood glucose control.He also had some issue with his humapen ergo ii device, the screw head of cartridge holder of pen was slippery and was not screwing tightly.He was not able to prime due to this issue (pc number: 5540160; lot number: unknown).Information regarding the corrective treatment and outcome of the event was not provided.Insulin lispro protamine suspension 75%/insulin lispro 25% therapy was continued.The operator of the humapen ergo ii device was patient himself and his training status was not provided.The general humapen ergo ii device model duration of use was not provided but it was started somewhere in 2019.The duration of use of suspect humapen ergo ii device was unknown.The action taken with suspect humapen ergo ii device was not provided and its return was not reported.The reporting consumer did not provide the relatedness assessment between the event or the suspect humapen ergo ii device.Edit 14apr2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 15-apr-2021: updated few eu/ca fields.No further changes were made to the case.

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 64-years-old asian male patient.Medical history included high blood pressure, high blood lipid, high cholesterol and high triglyceride.Concomitant medication included metformin for the treatment of diabetes mellitus.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog 25) from cartridge via humapen ergo ii device, 28 units twice daily subcutaneously, for the treatment of type ii diabetes, beginning somewhere in 2019.On an unknown date in (b)(6) 2021, while on insulin lispro protamine suspension 75%/insulin lispro 25% therapy, he got hospitalized due to poor blood glucose control.He also had some issue with his humapen ergo ii device, the screw head of cartridge holder of pen was slippery and was not screwing tightly.He was not able to prime due to this issue ((b)(4); lot number: unknown).Information regarding the corrective treatment and outcome of the event was not provided.Insulin lispro protamine suspension 75%/insulin lispro 25% therapy was continued.The operator of the humapen ergo ii device was patient himself and his training status was not provided.The general humapen ergo ii device model duration of use was not provided but it was started somewhere in 2019.The duration of use of suspect humapen ergo ii device was unknown.The suspect humapen ergo ii device was not returned to the manufacturer.The reporting consumer did not provide the relatedness assessment between the event or the suspect humapen ergo ii device.Edit 14apr2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 15-apr-2021: updated few eu/ca fields.No further changes were made to the case.Update 03may2021: additional information received on 03may2021 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 for (b)(4) associated with an unknown lot of a humapen ergo ii device.Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

B5.Narrative field: new, updated, and corrected information is referenced within the update statements in b5.Please refer to update statement(s) dated 03may2021 in the b5.Field.No further follow-up is planned.Evaluation summary a male patient reported that the screw thread of the cartridge holder of his humapen ergo ii device could not be attached tightly to the pen.The patient experienced abnormal blood glucose.The device was not returned to the manufacturer for investigation (batch number unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.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: 11695350
• MDR Text Key: 246797599
• Report Number: 1819470-2021-00057
• 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: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9557
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR
• Patient Weight: 80