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

Model Number MS9557

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Manufacturer Narrative

Since the device is not being returned, evaluation for a malfunction is not possible.A follow-up report will be submitted when the final evaluation is completed as necessary.

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 product complaint (pc), concerned an 89-years-old female patient of han nationality.Medical history, previous drug reaction and family drug reaction were none.Concomitant medications were not provided.The patient received insulin lispro (rdna origin) injections (humalog series insulin) from cartridge via a reusable pen, humapen ergo ii, at unknown dose, unknown dosing frequency, subcutaneously, for treatment diabetes mellitus, beginning on an unknown date in 2018 or 2019 (exact start date was not provided).On an unknown date in 2020 or 2021 (exact date was not provided) she had some issue in the humapen (pc: 6280596; lot number: unknown).On an unknown date, after starting insulin lispro therapy, she had high blood glucose and uncontrollable blood glucose and was hospitalized.She followed the advice of doctor to change to insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog 50) from cartridge, via a new reusable pen, humapen ergo ii, at dose of 12 units in morning and 10 units in evening, subcutaneously, for treatment of diabetes mellitus.After hospitalization and treatment (not specified), her blood glucose levels were 6-7 and 7-8 (units and reference range were not provided).On an unknown date, blood glucose control was okay (values, units and reference range were not provided).At night of 03-jan-2023, injection button of humapen was pushed down to the end directly without clicking sounds, she was not sure whether the insulin lispro protamine suspension 50%/insulin lispro 50% was injected into the body or not, the injection button of a humapen could not be pressed down next day (pc: 6280597; lot number: 1708d03).Further information regarding hospitalization and corrective treatment was not provided.Outcome of event blood glucose increased was recovered and outcome of another event was not provided.Insulin lispro therapy was discontinued and status of insulin lispro protamine suspension 50%/insulin lispro 50% therapy was not provided.Patient was the operator of the humapen, and her training status was not provided.Humapen device general model duration of use and suspect humapen devices duration of use were not provided.Action was taken with suspect humapens was not provided, return of first suspect device was not expected and return status of another device was unknown.The initial reporting consumer did not know if the events were related with insulin lispro and insulin lispro protamine suspension 50%/insulin lispro 50% therapies.The initial reporting consumer did not provide relatedness assessment of the events with first humapen ergo ii device and related the event of missed dose with issue of second suspect device and did not provide relatedness assessment of another event with second humapen ergo ii.Edit 25-jan-2023: upon review of the information received on 04-jan-2023, updated as reported and as determined causality of serious adverse event blood glucose increased with second humapen ergo ii device.No other changes were made to the case.Edit 02feb2023: 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 statement in b.5.Please refer to update statement dated 08feb2023 in the b.5.Field.No further follow-up is planned.Evaluation summary: a female patient reported that her humapen ergo ii had a malfunction (unspecified issue) in 2020 or 2021 (exact date was not provided).The patient experienced increased 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.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 spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint (pc), concerned an 89-years-old female patient of han nationality.Medical history, previous drug reaction and family drug reaction were none.Concomitant medications were not provided.The patient received insulin lispro (rdna origin) injections (humalog series insulin) from cartridge via a reusable pen, humapen ergo ii, at unknown dose, unknown dosing frequency, subcutaneously, for treatment diabetes mellitus, beginning on an unknown date in 2018 or 2019 (exact start date was not provided).On an unknown date in 2020 or 2021 (exact date was not provided) she had some issue in the humapen (pc: (b)(4); lot number: unknown).On an unknown date, after starting insulin lispro therapy, she had high blood glucose and uncontrollable blood glucose and was hospitalized.She followed the advice of doctor to change to insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog 50) from cartridge, via a new reusable pen, humapen ergo ii, at dose of 12 units in morning and 10 units in evening, subcutaneously, for treatment of diabetes mellitus.After hospitalization and treatment (not specified), her blood glucose levels were 6-7 and 7-8 (units and reference range were not provided).On an unknown date, blood glucose control was okay (values, units and reference range were not provided).At night of (b)(6) 2023, injection button of humapen was pushed down to the end directly without clicking sounds, she was not sure whether the insulin lispro protamine suspension 50%/insulin lispro 50% was injected into the body or not, the injection button of a humapen could not be pressed down next day (pc: (b)(4); lot number: 1708d03).Further information regarding hospitalization and corrective treatment was not provided.Outcome of event blood glucose increased was recovered and outcome of another event was not provided.Insulin lispro therapy was discontinued and status of insulin lispro protamine suspension 50%/insulin lispro 50% therapy was not provided.The patient was the operator of the humapen ergo ii devices, and her training status was not provided.The humapen ergo ii device general model duration of use and suspect humapen ergo ii devices duration of use were not provided.Action taken with suspect humapen ergo ii device (lot unknown) and humapen ergo ii device (lot 1708d03) were not provided.The suspect humapen ergo ii device (lot unknown) was not returned to manufacturer and humapen ergo ii device (lot 1708d03) was returned to the manufacturer.The initial reporting consumer did not know if the events were related with insulin lispro and insulin lispro protamine suspension 50%/insulin lispro 50% therapies.The initial reporting consumer did not provide relatedness assessment of the events with first humapen ergo ii device and related the event of missed dose with issue of second suspect device and did not provide relatedness assessment of another event with second humapen ergo ii.Edit 25-jan-2023: upon review of the information received on 04-jan-2023, updated as reported and as determined causality of serious adverse event blood glucose increased with second humapen ergo ii device.No other changes were made to the case.Edit 02feb2023: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 08feb2023: additional information received on 07feb2023 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information.Device with pc (b)(4) was not returned to manufacturer.Corresponding fields and narrative updated accordingly.

• 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: 16285904
• MDR Text Key: 308664929
• Report Number: 1819470-2023-00003
• 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: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• 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: 02/07/2023
• 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: 89 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian