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

Model Number MS9557

Device Problems Mechanical Problem (1384); Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964)

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

(b)(4).This report is associated with product complaint: pending.This solicited case, reported by a consumer via a patient support program (psp), concerned (b)(6) asian female patient.Medical history included diabetes for 2.5 years.Concomitant medications included metformin hydrochloride/ vildagliptin, acarbose and dapagliflozin propanediol monohydrate for diabetes.The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) injection (eglucent mix 25) via cartridge through re-usable humapen ergo ii unknown dose subcutaneously for treatment of diabetes mellitus beginning in 2019, for which dosage regimen was not reported.Since on an unknown date, while on insulin lispro protamine suspension 75%/ insulin lispro 25% (insulin lispro 75/25) treatment, her sugar level were never controlled, it used to fluctuate.She continued using insulin lispro 75/25 treatment till (b)(6) 2021.On (b)(6) 2021, she was hospitalized due to sugar level were never controlled, it fluctuate, where she was prescribed insulin lispro (rdna origin) injection eglucent rapid via prefilled kwikpen two doses daily, once before breakfast and once before lunch from (b)(6) 2021 for the treatment of diabetes.With eglucent rapid kwikpen her sugar levels were in control.She remained hospitalized till (b)(6) 2021.In 2021, she purchased eight eglucent rapid cartridge (stored in refrigerator) insulin lispro via cartridge through re-usable humapen ergo ii on (b)(6) 2021, but the medication was not coming out properly ((b)(4),5724335/lot-unknown, unknown).The medication from humapen ergo ii came out in force and not in a dropwise manner.She did not take medication in appropriate level (incomplete dose) due to which her sugar levels elevated from 92 in morning (checked before breakfast) and went till 245 in the afternoon and it shoot up till 475 in the night.On (b)(6) 2021, she purchased eglucent rapid kwikpen (disposable) and her issue was resolved.On (b)(6) 2021, after using insulin lispro kwikpen, she was experiencing hypoglycemia and was taking glucose.Her glucose level was 54.Outcome of incomplete dose and hypoglycemia was unknown, and outcome of remaining events was recovered.Insulin lispros treatment was continued.Insulin lispro 75/25 treatment status after discontinuation was not provided.The operator of the reusable humapen ergo ii device was patient and her training status was not provided.The general reusable humapen ergo ii device model duration of use and suspect reusable humapen luxura half dose device duration of use was approximately two years.Action taken with suspect device was not provided and device return status was not provided.The operator of the disposable device and his/her training status was not provided.The kwikpen model device duration of use was not provided but started in (b)(6) 2021 and suspect kwikpen device duration of use were not provided.The action taken with suspect device was not provided and kwikpen return was not expected.The reporting consumer was not sure about any relatedness between events and insulin lispro, insulin lispro 75/25 and humapen ergo ii device and kwikpen device.Update 27-sep-2021: additionally product complaint (pc) numbers: (b)(4) were received via affiliate on 21-sep-2021 via psp.No other medically significant information was received and no further changes were done to the case.Edit 05oct2021: updated medwatch and european and canadian (eu/ca) 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 27oct2021 in the b.5.Field.No further follow -up is planned.Evaluation summary: a female patient reported that on (b)(6) 2021 the medication from humapen ergo ii device "came out in force and not in a dropwise manner.She did not take medication in appropriate level (incomplete dose)." the patient experienced blood glucose fluctuation.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.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.There is no evidence of improper use or storage.

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 60-year-old asian female patient.Medical history included diabetes for 2.5 years.Concomitant medications included metformin hydrochloride/ vildagliptin, acarbose and dapagliflozin propanediol monohydrate for diabetes.The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) injection (eglucent mix 25) via cartridge through re-usable humapen ergo ii unknown dose subcutaneously for treatment of diabetes mellitus beginning in 2019, for which dosage regimen was not reported.Since on an unknown date, while on insulin lispro protamine suspension 75%/ insulin lispro 25% (insulin lispro 75/25) treatment, her sugar level were never controlled, it used to fluctuate.She continued using insulin lispro 75/25 treatment till (b)(6) 2021.On (b)(6) 2021, she was hospitalized due to sugar level were never controlled, it fluctuate, where she was prescribed insulin lispro (rdna origin) injection eglucent rapid via prefilled kwikpen two doses daily, once before breakfast and once before lunch from (b)(6) 2021 for the treatment of diabetes.With eglucent rapid kwikpen her sugar levels were in control.She remained hospitalized till (b)(6) 2021.In 2021, she purchased eight eglucent rapid cartridge (stored in refrigerator) insulin lispro via cartridge through re-usable humapen ergo ii on (b)(6) 2021, but the medication was not coming out properly ((b)(4) /lot-unknown, unknown).The medication from humapen ergo ii came out in force and not in a dropwise manner.She did not take medication in appropriate level (incomplete dose) due to which her sugar levels elevated from 92 in morning (checked before breakfast) and went till 245 in the afternoon and it shoot up till 475 in the night.On (b)(6) 2021, she purchased eglucent rapid kwikpen (disposable) and her issue was resolved.On (b)(6) 2021, after using insulin lispro kwikpen, she was experiencing hypoglycemia and was taking glucose.Her glucose level was 54.Outcome of incomplete dose and hypoglycemia was unknown, and outcome of remaining events was recovered.Insulin lispros treatment was continued.Insulin lispro 75/25 treatment status after discontinuation was not provided.The operator of the reusable humapen ergo ii device was patient and her training status was not provided.The general device model duration of use and suspect reusable humapen ergo ii device duration of use was approximately two years.Action taken with humapen ergo ii device was not provided.The suspect humapen ergo ii device (unknown lot) associated with product complaint (b)(4) was not returned to the manufacturer.The operator of the disposable kwikpen device and his/her training status was not provided.The kwikpen model device duration of use was not provided but started in (b)(6) 2021 and suspect kwikpen device duration of use were not provided.The action taken with suspect device was not provided and kwikpen return was not expected.The reporting consumer was not sure about any relatedness between events and insulin lispro, insulin lispro 75/25 and humapen ergo ii device and kwikpen device.Update 27-sep-2021: additionally product complaint (pc) numbers:(b)(4) and (b)(4) were received via affiliate on (b)(6) 2021 via psp.No other medically significant information was received and no further changes were done to the case.Edit 05oct2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 07-oct-2021: information received on 05-oct-2021 from rcp regarding pc number (b)(4).The same was processed in catool and updated in narrative accordingly.No new medically significant information was received and no further changes were done to the case.Update 27oct2021: additional information received on 22oct2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information, the european and canadian (eu/ca) device information for the suspect humapen ergo ii device (unknown lot) associated with product complaint (b)(4) which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.Edit 15nov2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.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
• Manufacturer (Section G): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285
• MDR Report Key: 12575731
• MDR Text Key: 281078824
• Report Number: 1819470-2021-00134
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2021

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: Other
• Device Model Number: MS9557
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/06/2021
• Initial Date FDA Received: 10/05/2021
• Supplement Dates Manufacturer Received: 10/22/2021
• Supplement Dates FDA Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian