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

Model Number MS9557

Device Problem Mechanical Jam (2983)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Manufacturer Narrative

Narrative field: new, updated and corrected information is referenced within the update statements.Please refer to update statement dated 02mar2022 in the field.No further follow-up is planned.Evaluation summary: a male patient reported that his humapen ergo ii device "could not be pressed." the patient experienced inadequate control of diabetes mellitus and abnormal 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 the needle was not changed for each injection.The core instructions for use state to use a new needle for each injection.There is evidence of improper use.The patient reused needles.This misuse may be relevant to the complaint and to the events of inadequate control of diabetes mellitus and abnormal 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 an adverse-events and a product complaint (pc), concerned a (b)(6) male patient of asian origin.Medical history included hypertension, coronary heart disease, gastric ulcer, penicillin allergy and family history included sister and parents had diabetes mellitus and son was allergic to penicillin.Concomitant medications included bo yi jing (as reported), essential, compound glycyrrhizin tablets, sodium bicarbonate tablets and hydrotalcite chewable tablets for unknown indication, metformin and glucobay orally for the treatment of orally for the treatment of type 2 diabetes mellitus.And another unspecified drug for unknown indication.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injection (humalog mix50) from a cartridge via unknown device, 20-30 units in morning and 18 units at night, subcutaneously for the treatment of type 2 diabetes mellitus since (b)(6) 2020.Since (b)(6) 2021, he started to use insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injection (humalog mix50) from a cartridge via a reusable device (humapen ergo ii), 18 units or 22 units or 24 units in the morning and 16 units at night, subcutaneously for the treatment of type 2 diabetes mellitus since 2021.On an unknown date in 2020, there were two layers in the humalog mix 50, one of the layers was transparent liquid and the other layer was floccule ((b)(4)/ lot no.# d069957aa).On an unknown date, his blood glucose was very high.He changes his dose to 10 in the morning and 8 at night.As of information received on 07-sep-2020, on an unknown date, he had lost 1 kg in weight, the blood glucose was suddenly high suddenly low.As of information received on 07-dec-2020, his blood glucose was abnormal.On an unknown date in (b)(6) 2020 and (b)(6) 2020, he experienced high fasting and postprandial blood glucose.As of information received on 02-mar-2021, in (b)(6) 2020, his body weight dropped to (b)(6) and in 2021 the body weight was risen to (b)(6).In feb-2021, his blood glucose measured was higher.As per doctor advise, he changed humalog mix50 dose from 28 units to 30 units in the morning because the blood glucose was too high and night dose of humalog mix50 was adjusted from 12 to 16 units based on the diet.As of information received on 17-jan-2022, he started to use humalog mix50 via reusable humapen ergo ii device at dose 18 units or 22 units or 24 units in the morning and 16 units at night, subcutaneously for the treatment of type 2 diabetes mellitus since 2021.On an unknown date, his blood glucose was not good, always had high pre-prandial blood glucose and high postprandial blood glucose, the blood glucose was high for too many days in a row, the pre-prandial blood glucose value was 10, the postprandial blood glucose was 12, 13 or 14.On an unknown date, insulin was very low, and his weight lost 14 kg.During the epidemic period, his weight was increased by17 kg, decreased by 2.5-3 kg in the middle, and rose back.His blood glucose was not adjusted well, added four bags of medicine a day (specific drug name was not provided), the effect was also not good, and unstable, and the weight also could not be reduced.He could not see clearly.On (b)(6) 2021, he was hospitalized (hospitalization reason was not provided) and he always went to the hospital to prescribe medicine every month (specific drug name was not provided).As of information received on 16-feb-2022, information obtained that on an unknown date, he had diabetes mellitus and poor blood glucose control due to which he was hospitalized on(b)(6 )2021.On (b)(6) 2022, the humapen ergo ii device could not be pressed ((b)(4)/ lot # unknown).He did not replace needle before every injection (improper use).On (b)(6) 2022, his measured blood glucose value was 24.Information regarding any corrective treatment, outcome of the events was not provided.Status of insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) was discontinued from (b)(6)2021 to (b)(6) 2021, and currently insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) was dose decreased.The operator of the humapen ergo ii device was patient himself and his training status was unknown.The general humapen ergo ii model duration of use and suspect humapen ergo ii duration of use was approximately 6 months, started on (b)(6) 2021.The action taken with the suspect humapen ergo ii device was no change, and its return status was not provided.The reporting consumer did not provide an assessment of relatedness between the events and insulin lispro protamine suspension 50%/insulin lispro 50% drug and humapen ergo ii device.Update 10-sep-2020: additional information received on 07-sep-2020 from the initial reporter.Added two lab tests and two new non-serious events of weight decreased and blood sugar increased.Updated the narrative with new information.Edit 14-sep-2020: upon review of initial information the case has been reopened to move to medical review state for car statement requirement in case and no other changes were done to the case.Update 10-dec-2020: additional information from the initial reporter via psp was received on 07-dec-2020.Added date of birth, six lab data and two non-serious events of blood glucose abnormal and blood glucose increased.Updated narrative with new information.Update 04-mar-2021: additional information from the initial reporter via psp was received on 02-mar-2021.Added a reporter, two medical histories, three dosage regimens to the suspect drug and two concomitant drugs, a non-serious event of weight increased.Updated action taken of suspect drug and narrative with new information.Updated 24-jan-2022: additional information from the initial reporter via psp was received on 17-jan-2022.Updated verbatim of medical history as sister and parents had diabetes mellitus, added six lab tests.Added two new drug dosage regimens, added one suspect device.Added two new non-serious events of visual impairment and blood glucose increased.Update 10-feb-2022: information received on 09-feb-2022 from the initial reporter via psp that the patient did not answer and then the patient hung up the phone directly, so no more information was obtained.No further changes were done to the case.Update 19-feb-2022: this case was initially determined to be non-serious.Additional information received on 16-feb-2022 from the initial reporter upgraded the case to serious.Added lab test and serious events diabetes mellitus inadequate control, and poor blood glucose control.Updated causality statement and narrative with new information.Update 02mar2022: additional information received on 25feb2022 from the global product complaint database.Entered device specific safety summary (dsss) for humapen ergo ii device associated with (b)(4), lot unknown.Updated the medwatch fields/ european and canadian (eu/ca) device information, device malfunction was updated from no to unknown as device was not returned to manufacturer.Corresponding fields and narrative updated accordingly.Edit 08-mar-2022: upon review of information on 16-feb-2022 significant tic was mark for the device in order to generate device report.No other changes were done in the case.

• 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: 13722674
• MDR Text Key: 286952115
• Report Number: 1819470-2022-00023
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• 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: 02/16/2022
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian