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

Model Number MS9557

Device Problems Difficult or Delayed Activation (2577); Mechanical Jam (2983)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 01/31/2020

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.This report is associated with 1819470-2022-00013 since there is more than one device implicated.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer, concerns a (b)(6) female patient with ethnicity reported as (b)(6).Reportedly, patient did not have any history of complicating disease, allergic history, family medical history or previous drug adverse reaction.Concomitant medication included dapagliflozin, glimepiride and metformin, all for unknown indication.The patient received human insulin regular 30% + human insulin nph 70% (rdna origin) (humulin 70/30) from cartridges via humapen ergo ii device, 16 in the morning, 10 at noon and 12 at night (units not provided), subcutaneously, for diabetes mellitus, beginning on an unspecified date around 2008.On an unspecified date, the humapen ergo ii injection button could not be pressed during the injection (lot number 0805d02, product complaint (b)(4)).On an unspecified date in 2020, the patient started using another humapen ergo ii (lot number 1707d01).It was unknown if the previous humapen ergo ii was discontinued.On an unspecified date in 2020, unknown time after commencing human insulin regular 30% + human insulin nph 70% and unclear via which humapen ergo ii device, the patient was hospitalized for high blood glucose.Further details were not provided.On an unspecified date in 2021, the injection button of the new humapen ergo ii also could not be pressed during the injection (lot number 1707d01, product complaint (b)(4)).On an unspecified date in the summer of 2021, unclear if after issue with second humapen ergo ii device, the patient had high blood sugar again.Reportedly, the injection did more than before, more and more severe (as reported), but further information was not provided.It was unknown if patient received any corrective treatment, if laboratory exams were performed and if the patient recovered from the events.As of (b)(6) 2022, the injection site button of the humapen ergo ii lot 1707d01 was getting worse and treatment with human insulin regular 30% + human insulin nph 70% was ongoing, but dose regimen had been changed to at 24 in the morning and 28 at night (unit not provided).It was reported that it was changed according to doctor advise, but date and reason for change was not provided.It was unknown who operated the devices and if operator was trained.The duration for use for this device model was around 14 years, of the humapen ergo ii lot 0805d02 was unknown and of the humapen ergo ii lot 1707d01 was around two years.The status of humapen ergo ii lot 0805d02 was unknown and the humapen ergo ii lot 1707d01 was continued.Return status of the devices was not provided.The reporting consumer did not know if the events were related to human insulin regular 30% + insulin nph 70% or to the humapen ergo ii devices.Edit 16feb2022: updated medwatch 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, concerns a 50-year-old female patient with ethnicity reported as han.Reportedly, patient did not have any history of complicating disease, allergic history, family medical history or previous drug adverse reaction.Concomitant medication included dapagliflozin, glimepiride and metformin, all for unknown indication.The patient received human insulin regular 30% + human insulin nph 70% (rdna origin) (humulin 70/30) from cartridges via humapen ergo ii device, 16 in the morning, 10 at noon and 12 at night (units not provided), subcutaneously, for diabetes mellitus, beginning on an unspecified date around 2008.On an unspecified date, the humapen ergo ii injection button could not be pressed during the injection (lot number 0805d02, product complaint (b)(4)).On an unspecified date in 2020, the patient started using another humapen ergo ii (lot number 1707d01).It was unknown if the previous humapen ergo ii was discontinued.On an unspecified date in 2020, unknown time after commencing human insulin regular 30% + human insulin nph 70% and unclear via which humapen ergo ii device, the patient was hospitalized for high blood glucose.Further details were not provided.On an unspecified date in 2021, the injection button of the new humapen ergo ii also could not be pressed during the injection (lot number 1707d01, product complaint (b)(4)).On an unspecified date in the summer of 2021, unclear if after issue with second humapen ergo ii device, the patient had high blood sugar again.Reportedly, the injection did more than before, more and more severe (as reported), but further information was not provided.It was unknown if patient received any corrective treatment, if laboratory exams were performed and if the patient recovered from the events.As of (b)(6) 2022, the injection site button of the humapen ergo ii lot 1707d01 was getting worse and treatment with human insulin regular 30% + human insulin nph 70% was ongoing, but dose regimen had been changed to at 24 in the morning and 28 at night (unit not provided).It was reported that it was changed according to doctor advise, but date and reason for change was not provided.It was unknown who operated the devices and if operator was trained.The duration for use for this device model was around 14 years, of the humapen ergo ii lot 0805d02 was unknown and of the humapen ergo ii lot 1707d01 was around two years.The status of humapen ergo ii lot 0805d02 was unknown and the humapen ergo ii lot 1707d01 was continued.Devices were returned to manufacturer.The reporting consumer did not know if the events were related to human insulin regular 30% + insulin nph 70% or to the humapen ergo ii devices.Edit 16feb2022: updated medwatch fields for expedited device reporting.No new information added.Update 02mar2022: additional information received on 28feb2022 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information for (b)(4) associated with lot number 0805d02 and (b)(4) associated with lot number 1707d01 with humapen ergo ii devices.Updated malfunction from unknown to no, date of manufacturer, device return status to returned to manufacturer, and date returned to manufacturer for both the devices.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 (s) dated 02mar2022 in the b.5.Field.No further follow-up is planned.This report is associated with 1819470-2022-00013 since there is more than one device implicated.Evaluation summary: a female patient reported that the injection button of her humapen ergo ii device could not be pressed.She experienced increased blood glucose.The investigation of the returned device (batch 0805d02, manufactured may 2008) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.While it is unknown how long the patient used the device, based on the amount of time elapsed since the device was manufactured (may 2008), it is likely the patient used it beyond its approved use life.The user manual states the humapen ergo ii has been designed to be used for up to 3 years after first use.There is evidence of improper use.The patient likely used the device beyond the recommended use period.This misuse may not be relevant to the complaint or the event of increased blood glucose, as the returned device met performance specifications.

• 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: 13551151
• MDR Text Key: 289878413
• Report Number: 1819470-2022-00014
• 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: 03/23/2022

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: Other
• Device Model Number: MS9557
• Device Lot Number: 0805D02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 02/17/2022
• Initial Date FDA Received: 02/17/2022
• Supplement Dates Manufacturer Received: 02/28/2022
• Supplement Dates FDA Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2008
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian