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

Model Number MS9557

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Deliver (2338); Difficult or Delayed Activation (2577); Mechanical Jam (2983)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Manufacturer Narrative

If device is returned, evaluation will be performed to determine if a malfunction has occurred.A follow-up report will be submitted when the final evaluation is completed.This report is associated with 1819470-2021-00173 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 who contacted the company to report adverse events, concerned a (b)(6) (at the time of initial report) chinese han male patient.Medical history included diabetes since 2011 and hypertension.Concomitant medications included the use of metformin and nateglinide, both for the treatment of unknown indications.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix25) from a cartridge formulation, via humapen ergo ii, 18 units in the morning and 20 units at night, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date in apr-2016.On an unknown while on insulin lispro protamine suspension 75%/insulin lispro 25%), the injection screw had problem, and the injection button could not be depressed, if an insulin cartridge was installed and reinjected, sometimes it was good, sometimes it was not.At present it was unclear that whether the insulin injection pen was improperly operated or the insulin injection pen had already been damaged resulted in the failure to inject according to the doctor's advice.On unknown dates, he received insufficient insulin injection dosage, and his blood glucose increased to 33, due to which he was hospitalized on (b)(6) 2021 and discharged on (b)(6) 2021 (pc no:(b)(4) , lot no: unknown), (pc no:(b)(4), lot no: unknown).On unknown dates, during hospitalization, he had skin pruritus, affected renal function and weight loss.After hospitalization the dosage was decreased to 16 units in the morning and 20 units at night.Since (b)(6) 2021, he again did not receive the medication as per the doctor's advice, due to unspecified reasons.On unknown dates, he had used the same humapen ergo ii since 2016 (improper use) and was ongoing.Further information regarding corrective treatment was unknown.Outcome for the events was unknown.Therapy status of insulin lispro protamine suspension 75%/insulin lispro 25% was ongoing.The operator of the humapen ergo ii was patient her training status was not provided.The general humapen ergo ii model duration of use was 5 years and 6 months and the suspect humapen ergo ii duration of use was five and a half yrs for the first humapen ergo ii and 2 years 4 months for the second suspect humapen ergo ii.Suspect humapen ergo ii use continued for both the devices, the usage concerns were not resolved and their return was expected.The initial reporting consumer assessed the relatedness of the events to the insulin lispro protamine suspension 75%/insulin lispro 25% therapy as unknown.The additional reporting consumer did not provide relatedness of events with humapen ergo ii.The skin pruritus, affected renal function and weight loss were believed to be due to increased blood glucose.Update 02-dec-2021: all the information received on 29-nov-2021 and 30-nov-2021, was processed together.Edit 14dec2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 16dec2021: 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 22dec2021 in the b.5.Field.No further follow-up is planned.Evaluation summary.A male patient reported that the injection screw of his humapen ergo ii device "had a problem, and the injection button could not be depressed, if an insulin cartridge was installed and reinjected, sometimes it was good, sometimes it was not." he reported he received insufficient insulin.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 with high probability.The patient reported that he had used the device for five and a half years.The core instructions for use state 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 used the device beyond the recommended use period.It is unknown if the misuse is relevant to the event of increased blood glucose.

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, concerned a 57-year-old(at the time of initial report) chinese han male patient.Medical history included diabetes since 2011 and hypertension.Concomitant medications included the use of metformin and nateglinide, both for the treatment of unknown indications.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix25) from a cartridge formulation, via humapen ergo ii, 18 units in the morning and 20 units at night, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date in (b)(6) 2016.On an unknown while on insulin lispro protamine suspension 75%/insulin lispro 25%), the injection screw had problem, and the injection button could not be depressed, if an insulin cartridge was installed and reinjected, sometimes it was good, sometimes it was not.At present it was unclear that whether the insulin injection pen was improperly operated or the insulin injection pen had already been damaged resulted in the failure to inject according to the doctor's advice.On unknown dates, he received insufficient insulin injection dosage, and his blood glucose increased to 33, due to which he was hospitalized on (b)(6) 2021 and discharged on (b)(6) 2021 (pc no:5798576 , lot no: unknown), (pc no:5801775, lot no: unknown).On unknown dates, during hospitalization, he had skin pruritus, affected renal function and weight loss.After hospitalization the dosage was decreased to 16 units in the morning and 20 units at night.Since (b)(6) 2021, he again did not receive the medication as per the doctor's advice, due to unspecified reasons.On unknown dates, he had used the same humapen ergo ii since 2016 (improper use) and was ongoing.Further information regarding corrective treatment was unknown.Outcome for the events was unknown.Therapy status of insulin lispro protamine suspension 75%/insulin lispro 25% was ongoing.The operator of the humapen ergo ii was patient her training status was not provided.The general humapen ergo ii model duration of use was 5 years and 6 months and the suspect humapen ergo ii duration of use was five and a half yrs for the first humapen ergo ii and 2 years 4 months for the second suspect humapen ergo ii.Suspect humapen ergo ii use continued for both the devices, the usage concerns were not resolved and was not returned to manufacturer.The initial reporting consumer assessed the relatedness of the events to the insulin lispro protamine suspension 75%/insulin lispro 25% therapy as unknown.The additional reporting consumer did not provide relatedness of events with humapen ergo ii.The skin pruritus, affected renal function and weight loss were believed to be due to increased blood glucose.Update 02-dec-2021: all the information received on 29-nov-2021 and 30-nov-2021, was processed together.Edit 14dec2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 16dec2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 22dec2021: additional information received on 21dec2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information for pc 5798576 associated with unknown lot of humapen ergo ii device.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: 13018845
• MDR Text Key: 287810795
• Report Number: 1819470-2021-00172
• 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: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• 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?: Yes
• Date Manufacturer Received: 12/21/2021
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian