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

Model Number MS9557

Device Problems Excess Flow or Over-Infusion (1311); Mechanical Problem (1384); Inaccurate Delivery (2339); Mechanical Jam (2983)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

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 a consumer who contacted the company to report adverse events and a product complaint (pc), concerned a (b)(6) (at the time of initial report) asian female patient.Medical histories were unknown.Concomitant medication included metformin used for an unknown indication.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injection (humalog, mix 25), from a cartridge via a reusable pen humapen ergo ii, at 16 units in the morning, subcutaneously for the treatment of diabetes mellitus, beginning on an unknown date in 2020.On 13-may-2022, she started using humapen ergo ii.On an unknown date, after starting the insulin lispro protamine suspension 75%/insulin lispro 25% therapy, the dose was changed to 18 units in morning due to an unknown reason per doctor advise.On an unknown date, while on insulin lispro protamine suspension 75%/insulin lispro 25% therapy, due to the malfunction of the injection pen she injected too much insulin and the dosage was inaccurate which caused the hypoglycemia (pc number: 5991840/lot number: 1906d03), the blood glucose was sudden high and sudden low (exact values, units and reference ranges were unknown), dizzy, fell in a faint in the morning, was very uncomfortable.The events of fall, faint, discomfort, blood glucose increased, and hypoglycemia were considered as serious by the company due to their medically significant reasons.Further information regarding the corrective treatment and outcome of the events were unknown.The insulin lispro protamine suspension 75%/insulin lispro 25% treatment was continued.The operator of the humapen ergo ii was the patient and her training status was not provided.The humapen ergo ii general model duration and suspect duration of use was not reported however it was started on (b)(6) 2022.The action taken with humapen ergo ii and its return status were not provided.The initial reporting consumer did not know if all the events were related with insulin lispro protamine suspension 75%/insulin lispro 25% therapy.The reporting consumer considered that the event of incorrect dose administered was due to product complaint issue of humapen ergo ii and did not report if the remaining events were related to humapen ergo ii.Update 31-may-2022: initial and follow up documents received on 26-may-2022 was processed together.Edit 02-jun-2022: upon review of the information received on 26-may-2022, added the seriousness criteria in narrative only.Edit 02jun2022: updated medwatch and (b)(6) (eu/ca) 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 spontaneous case reported by a consumer who contacted the company to report adverse events and a product complaint (pc), concerned a 56-year-old (at the time of initial report) asian female patient.Medical histories were unknown.Concomitant medication included metformin used for an unknown indication.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injection (humalog, mix 25), from a cartridge via a reusable pen humapen ergo ii, at 16 units in the morning, subcutaneously for the treatment of diabetes mellitus, beginning on an unknown date in 2020.On (b)(6) 2022, she started using humapen ergo ii.On an unknown date, after starting the insulin lispro protamine suspension 75%/insulin lispro 25% therapy, the dose was changed to 18 units in morning due to an unknown reason per doctor advise.On an unknown date, while on insulin lispro protamine suspension 75%/insulin lispro 25% therapy, due to the malfunction of the injection pen she injected too much insulin and the dosage was inaccurate which caused the hypoglycemia (pc number: (b)(4)/lot number: 1906d03), the blood glucose was sudden high and sudden low (exact values, units and reference ranges were unknown), dizzy, fell in a faint in the morning, was very uncomfortable.The events of fall, faint, discomfort, blood glucose increased, and hypoglycemia were considered as serious by the company due to their medically significant reasons.Further information regarding the corrective treatment and outcome of the events were unknown.The insulin lispro protamine suspension 75%/insulin lispro 25% treatment was continued.The operator of the humapen ergo ii was the patient and her training status was not provided.The humapen ergo ii general model duration and suspect duration of use was not reported however it was started on (b)(6) 2022.The action taken with humapen ergo ii and was not returned to the manufacturer.The initial reporting consumer did not know if all the events were related with insulin lispro protamine suspension 75%/insulin lispro 25% therapy.The reporting consumer considered that the event of incorrect dose administered was due to product complaint issue of humapen ergo ii and did not report if the remaining events were related to humapen ergo ii.Update 31-may-2022: initial and follow up documents received on 26-may-2022 was processed together.Edit 02-jun-2022: upon review of the information received on 26-may-2022, added the seriousness criteria in narrative only.Edit 02jun2022: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 14-jun-2022: information received from the local affiliate on 13-jun-2022.No new medically significant information was received.No further changes were made to the case.Update 27jun2022: additional information received on 21jun2022 from the global product complaint database.Entered device specific safety summary (dsss) for humapen ergo ii device associated with pc (b)(4), lot 1906d03.Updated the medwatch fields/ european and canadian (eu/ca) device information and device return status to not returned to manufacturer.Added date of manufacturer for the device and improper use or storage was updated from no to yes.Corresponding fields and narrative updated accordingly.

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 27jun2022 in the b.5.Field.No further follow-up is planned.Evaluation summary: a pharmacy staff person reported on behalf of a female patient that the injection button of her humapen ergo ii device was stuttering in pressing since she started to use it on (b)(6) 2022.The device could not return to zero during injection and could not be primed on (b)(6) 2022, and the patient alleged that due to the malfunction of the injection pen, she injected too much insulin and the dosage was inaccurate.The patient experienced increased blood glucose and hypoglycemia.The device was not returned to the manufacturer for investigation (batch 1906d03, manufactured june 2019).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review did not identify any atypical findings with regard to pen jammed, dose accuracy, or device not working 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 core instructions for use state if any of the parts of your humapen ergo ii appear broken or damaged, do not use, and to always carry a spare insulin pen in case your pen is lost or damaged.There is evidence of improper use.The patient continued to use the device after experiencing the alleged complaint issue.This may be relevant to the event of hypoglycemia if the patient applied another dose of insulin.It is unknown if the complaint issue is relevant to the event of increased blood glucose.

• Brand Name: HUMAPEN ERGO II
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): TECH GROUP NORTH AMERICA INC. DBA WEST; 640 south rockford drive; tempe AZ 85281
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 14575407
• MDR Text Key: 293378812
• Report Number: 1819470-2022-00041
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 1906D03
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/26/2022
• Initial Date FDA Received: 06/02/2022
• Supplement Dates Manufacturer Received: 06/21/2022
• Supplement Dates FDA Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian