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

Model Number MS9557

Device Problem Failure to Deliver (2338)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Type  Injury  

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 a 60-year-old male patient of unknown origin.Medical history was not provided.Concomitant medications included metformin, dapagliflozin and 30 unspecified insulins for diabetes mellitus.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injection (humalog mix 50) from cartridge via reusable pen humapen unknown, at an unknown dose three times a day, via subcutaneous route, for the treatment of diabetes mellitus, beginning on an unknown date in 2020.On (b)(6) 2022, he experienced a slight hypoglycemia, he broke the injection pen and then the patient lost consciousness (no units and reference range provided).The event of hypoglycemia and lost consciousness was considered as serious by company due to medically significant reason.The injection pen was cracked and broke off (batch unknown pc # (b)(4) when he lost consciousness.On an unspecified time, he came to senses.On an unspecified date, he developed hypoglycemia.It was treated every day by eating two o three pieces of sugar cubes if he had hypoglycemia, and prepared high-sugar drinks.Due to the epidemic situation, the city was closed, and he had no insulin.Under the doctor advice he started using, insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injection (humalog mix 25) from cartridge, unknown dose and frequency, via subcutaneously for the treatment of diabetes mellitus, beginning on (b)(6) 2022.On an unspecified date, after starting insulin lispro protamine suspension 75%/insulin lispro 25%, he developed hypoglycemia.Reportedly every night he was afraid of hypoglycemia, blood glucose was measured at 12 to 1 pm.He placed high sugar drinks and sugar cubes beside the bed.On (b)(6) 2022, the blood glucose was high (no reference range was provided).The insulin lispro protamine suspension 75%/insulin lispro 25%, was used.It was not useful and did not respond.The blood glucose value measured was: 16, he injected 21 units, after two hours, blood glucose measured, and it did not drop.He did not eat, injected 20 units by self again, and then fell asleep.When he woke up and measured the blood glucose value, it was 12-13.He was afraid that the blood glucose would not drop, reportedly he had insulin resistance, and drug resistance.On an unspecified date one insulin lispro protamine suspension 75%/insulin lispro 25% had no effect, and lost efficacy (pc (b)(4); lot-unknown).In (b)(6) 2022, according to the doctors advice, fasting blood glucose was measured.Examination report was checked: glycosylated hemoglobin, the average value of three months was: 7-8 (no units were provided).On (b)(6) 2022, he bought 30 unspecified insulin, reportedly it was useless after injection, suspected whether the insulin lost efficacy, whether it was insulin resistance, and the blood glucose value measured was also 10-20 (no units were provided).On (b)(6) 2022, the doctor said, he used insulin did not work because of insulin resistance, he asked to do blood drawing and urine tests and urine glucose tests.On (b)(6) 2022, fasting blood glucose test was performed.The results were: glycosylated hemoglobin (mean value of 3 months) was: 8-9, fasting blood glucose was 10-20 (no units were provided).On (b)(6) 2022, the doctor gave five injections of insulin lispro protamine suspension 50%/insulin lispro 50%, and he started 20 units, three times a day according to the doctors advice.The fasting blood glucose value measured in the morning was: 5.8 (no units were provided).After taking it according to the doctors advice, he felt no drug resistance, and the blood glucose value was relatively satisfactory, indicating that it was useful.It was just fine.The blood glucose had been measured for several days, blood glucose values were: 12-13, 11.9, 12.4, and 15 or 16 (no units were provided).The fasting blood glucose value in the morning several times were: 8.1 (no units were provided).On (b)(6) 2023 morning, after injection insulin lispro protamine suspension 50%/insulin lispro 50% via humapen ergo ii device, because the blood glucose could not be lowered, 25 units were injected spontaneously again, noodles were eaten at noon, half an hour later, the feet were swollen, and the feet were numb, feeling blood glucose was high at that time, but did not measure the blood glucose value, 25 units were injected again, coarse grain pancake were eaten at night.The feet swollen more severely after eating, 28 units were injected again.On (b)(6) 2023, the blood glucose value measured was: 25.9, at that time he found that it was caused by the failure of the injection pen (pc 6278346/lot unknown).He changed another injection pen to inject 33 units of insulin.The blood glucose value was measured and was 2.3, hypoglycemia.Reportedly the blood glucose value was high for a little while, low for a little while, it was not a problem with the liquid medicine, but the problem with the injection pen, and then he took sugar cube, he was improving.Since an unspecified date, he had poor memory and almost blind eyes (improper use).The event of almost blind eyes was considered as serious by the company due to medically significant reasons.He was recovering from hypoglycemia and high blood glucose.Information about corrective treatments and outcome of the remaining events was not provided.The status of insulin lispro protamine suspension 50%/insulin lispro 50% therapy and insulin lispro protamine suspension 75%/insulin lispro 25% therapy were not provided.Follow up not possible with reporter as consent to contact not gained and hcp details were also not provided by the reporter.The patient was the operator of the humapen unknown/ humapen ergo ii and his training status was not provided.The general model device duration and the suspect devices duration of use were unknown.Action taken with the suspect devices was unknown and both devices were not returned to manufacturer.The reporting consumer related the event of drug has no effect with insulin lispro protamine suspension 75%/insulin lispro 25%, did not provide its relatedness with insulin lispro protamine suspension 50%/insulin lispro 50% and did not know if the remaining events were related to the insulin lispro protamine suspension 50%/insulin lispro 50% or insulin lispro protamine suspension 75%/insulin lispro 25% therapies and the humapen unknown device or humapen ergo ii.Edit (b)(6) 2022: updated medwatch fields for expedited device reporting.No new information added.Update (b)(6) 2022: additional information received on 12aug2022 from the global product complaint database.Entered device specific safety summary (dsss) for humapen, unknown device associated with pc 6065429, lot unknown.Updated the medwatch fields/ european and canadian (eu/ca) device information and device return status to not returned to manufacturer.Corresponding fields and narrative updated accordingly.Edit (b)(6) 2022: upon review of information received on (b)(6) 2022 by affiliate, corrected the statement related to product complaint.No other changes were made to the case.Update (b)(6) 2023: additional information was received from the initial reporter via a psp on (b)(6) 2023.Added: one serious event: almost blind; eight non-serious events: glycosylated hemoglobin was 7 to 8, hypoglycemia, insulin resistance, poor memory, feet were numb, feet were swollen, blood glucose was high and lack of drug effect; one suspect drug humalog 25, one suspect device humalog ergo ii device; concomitant medication: dapagliflozin and metformin; laboratory test and patient demographics.Updated the narrative with new information.Edit (b)(6) 2023: upon review of information, updated the narrative first para from concerned a 60-year-old male patient of unknown age and origin to concerned a 60-year-old male patient of unknown origin.No other changes were made to the case.Update 27jan2023: additional information received on 24jan2023 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information and improper use from no to yes and device was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

Narrative field: new, updated, and corrected information is referenced within the update statement in b.5.Please refer to update statement dated 27jan2023 in the b.5.Field.No further follow-up is planned.This report is associated with 1819470-2022-00055 since there is more than one device.Evaluation summary a patient reported that the injection button of his humapen ergo ii could be pressed but no medication flowed out.The patient experienced a serious event of hypoglycemic unconsciousness and non-serious events of increased blood glucose and hypoglycemia.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 devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.The patient reported visual impairment.The core instructions for use state that the device is not recommended for the visually impaired without the assistance of a sighted individual trained to use it.There is evidence of improper use.The patient used the device while visually impaired.It is unknown if this misuse is relevant to the complaint or events of serious hypoglycemic unconsciousness, or nonserious increased blood glucose and hypoglycemia.

• 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: 16269362
• MDR Text Key: 308441131
• Report Number: 1819470-2023-00002
• 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: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• 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: 01/03/2023
• 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): Other
• Patient Age: 60 YR
• Patient Sex: Male