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

Model Number MS9557

Device Problems Leak/Splash (1354); Difficult or Delayed Activation (2577); Mechanical Jam (2983)

Patient Problem Hyperglycemia (1905)

Event Date 07/24/2021

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 device was associated with hospitalization for abnormal blood glucose on an unreported date in 2020 and hospitalization for increased blood glucose on (b)(6) 2021.

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 (b)(6)-year-old (b)(6) female patient.Medical history included osteoporosis, hypoglycemia, dizziness, cardiovascular and cerebrovascular diseases, brain white matter denaturation and hospitalization for unknown reason.She had stomach bulging at night after taking acarbose in past for unknown indication.Concomitant medications included acarbose, zoledronic acid, rosuvastatin calcium, conditioning traditional chinese medicine granules and ginkgo biloba, all for the treatment of unknown indication.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injection (humalog 25) via a cartridge from a reusable device (humapen ergo ii) (blue, plastic), twice daily (8 units on an empty stomach in the morning and 6 units on an empty stomach in the evening), subcutaneously for diabetes mellitus, beginning approximately in 2015 or 2016.On an unknown date, she lost weight (b)(6), and her blood glucose was unstable, hypoglycemia/low glucose.Reportedly, she did not dare to eat more since if she ate more, her blood glucose would be high.She checked the islet function and indicated that there was no islet function and she could not stop using insulin since there was dependence.On an unknown date, she changed her dose from 8 units in morning/6 units in evening to 13 units (on an empty stomach) in the morning and 8 units (on an empty stomach) in the evening by herself.On (b)(6) 2018, while on insulin lispro protamine suspension 75%/insulin lispro 25% treatment, she had a car accident on foot while walking and got hospitalized due to the event on same day.Since 2019 or 2020, her body was gradually getting worse/health had gradually deteriorated, with palpitation and lack of strength, was panic, had presbyopia and her height became shorter (from 160cm to 157 cm).In 2020, she was hospitalized again to get a zoledronic acid injection and to regulate blood glucose (value, units and reference range were not provided).On (b)(6) 2021, humapen ergo ii could not be pushed down and insulin came out drop by drop after injection.On (b)(6) 2021, her blood glucose was high (highest, it was 28.6) due to humapen ergo ii issue (lot number: 1609d01, pc number: (b)(4)) so she was admitted in the hospital.After treatment, her blood glucose value was 22.6 and fasting blood glucose was 15.7 on (b)(6) 2021.Information regarding corrective treatment of remaining events and outcome of remaining events was unknown.Status of insulin lispro protamine suspension 75%/insulin lispro 25% treatment was ongoing.The patient was the operator of humapen ergo ii and her training status was not provided.The general humapen ergo ii duration and suspect humapen ergo ii duration was not provided.The status of humapen ergo ii was not provided and its return was expected.The initial reporting consumer did not know if the events were related to insulin lispro protamine suspension 75%/insulin lispro 25% treatment.The reporting consumer related the event of high blood glucose at 28.6 with the product complaint associated with humapen ergo ii, did not provide relatedness of blood glucose abnormal, blood glucose unstable and hypoglycemia and did not associate remaining events with humapen ergo ii.Update 29-jul-2021: all the information received on 26-jul-2021, 27-jul-2021 and 28-jul-2021 were processed at same time.Update 03-aug-2021: information was received from initial reporter on 28-jul-2021 regarding the previously captured product complaint information.No new medically significant information was reported and no changes were made to the case.Edit 13aug2021: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.Edit 18aug2021: updated medwatch and european and (b)(6) (eu/(b)(6)) 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 28sep2021 in the b.5.Field.No further follow-up is planned.This is a downgrade report that no longer meets the criteria for expedited reporting.This device was associated with hospitalization for abnormal blood glucose on an unreported date in 2020 and hospitalization for increased blood glucose on (b)(6) 2021.This report is associated with 1819470-2021-00130 and 1819470-2021-00131 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 pushed down.And insulin came out drop by drop after injection.The investigation of the returned device (batch 1609d01, manufactured september 2016) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.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 80-year-old chinese han female patient.Medical history included osteoporosis, hypoglycemia, dizziness, cardiovascular and cerebrovascular diseases, high blood fat, high blood lipid, prolapse of gastric mucosa, brain white matter denaturation and hospitalization for unknown reason.She had stomach bulging at night after taking acarbose in past for unknown indication.Concomitant medications included acarbose, zoledronic acid, conditioning traditional chinese medicine granules and ginkgo biloba, all for the treatment of unknown indication.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injection (humalog 25) via a cartridge from a reusable device (humapen ergo ii), twice daily (8 units on an empty stomach in the morning and 6 units on an empty stomach in the evening), subcutaneously for diabetes mellitus, beginning approximately in 2015 or 2016.On an unknown date, she lost weight (from 52.5-53 kg to 42-42.5 kg), and her blood glucose was unstable, hypoglycemia/low glucose.Reportedly, she did not dare to eat more since if she ate more, her blood glucose would be high.Since an unknown date, after the injection in the belly, sometimes it hurt, sometimes it did not hurt, and sometimes there was bleeding.Since an unknown date, her blood glucose was suddenly high and suddenly low(no values, units and reference range were provided).When her blood glucose was not well controlled she had palpitation, could not see clearly with blurring in right eye, sweating with no strength, she only wanted to sleep.She checked the islet function and indicated that there was no islet function and she could not stop using insulin since there was dependence.On an unknown date, she changed her dose from 8 units in morning/6 units in evening to 14 units (on an empty stomach) in the morning and 8 units (on an empty stomach) in the evening by herself.On (b)(6) 2018, while on insulin lispro protamine suspension 75%/insulin lispro 25% treatment, she had a car accident on foot while walking and got hospitalized due to the event on same day.Since 2019 or 2020, her body was gradually getting worse/health had gradually deteriorated, with palpitation and lack of strength, was panic, had presbyopia and her height became shorter (from 160cm to 157 cm).In 2020, she was hospitalized again to get a zoledronic acid injection and to regulate blood glucose (value, units and reference range were not provided).Since an unknown date, she had cataract in her eyes.Cataract in her left eye was operated in sep-2017 whereas, cataract in right eye was operated in on (b)(6) 2021.On an unknown date, she had headache for which she took rosuvastatin.On an unknown date in (b)(6) 2021, humapen ergo ii device was leaking (lot number:unknown pc number: (b)(4).On (b)(6) 2021, humapen ergo ii could not be pushed down and insulin came out drop by drop after injection.On (b)(6) 2021, her blood glucose was high (highest, it was 28.6) due to humapen ergo ii issue (lot number: 1609d01, pc number: (b)(4) so she was admitted in the hospital.After treatment, her blood glucose value was 22.6 and fasting blood glucose was 15.7 on (b)(6) 2021.On (b)(6) 2021, when humapen ergo ii injection button was pressed down there was no clicking sound and insulin lispro protamine suspension 75%/insulin lispro 25% was leaking out (lot number 1806d01 pc number: (b)(4).On (b)(6) 2021, she had an issue with humapen ergo ii and she was not sure whether insulin lispro protamine suspension 75%/insulin lispro 25% was injected or not.On (b)(6) 2021, blood glucose was 25.5 and at night it was 28 (no units and reference range were provided).Reportedly, she used humapen ergo ii (unknown lot number) for more than three years and she also had cataract.The outcome of the weight decreased was not resolved.Information regarding corrective treatment of remaining events and outcome of remaining events was unknown.Status of insulin lispro protamine suspension 75%/insulin lispro 25% treatment was ongoing.The patient was the operator of humapens ergo ii and her training status was not provided.The general humapens ergo ii duration of use was not provided.The suspect humapen ergo ii duration of use (unknown lot)was six years whereas, suspect humapen ergo ii duration with lot number (1806d01) was fifty two days.The suspect humapen ergo ii ( lot number 1609d01) associated with product complaint number (b)(4) duration of use was not provided.The action taken with humapen ergo ii with lot number (1609d01) not provided.The action taken with humapen ergo ii with lot number (1806d01) not provided and its return was not expected.The humapen ergo ii with unknown lot use was discontinued hence, its return status was not provided.The suspect humapen ergo ii ( lot number 1609d01) associated with product complaint number (b)(4) was returned to the manufacturer on 16aug2021.The initial reporting consumer did not know if the events were related to insulin lispro protamine suspension 75%/insulin lispro 25% treatment.The reporting consumer related the event of high blood glucose at 28.6, blood glucose fluctuation, blood sugar abnormal, hypoglycemia, product dose omission with the product complaint associated with humapen ergo ii, did not provide relatedness of events of injection site pain and injection site bleeding and did not associate remaining events with humapen ergo ii.Update 29-jul-2021: all the information received on 26-jul-2021, 27-jul-2021 and 28-jul-2021 were processed at same time.Update 03-aug-2021: information was received from initial reporter on (b)(6) 2021 regarding the previously captured product complaint information.No new medically significant information was reported and no changes were made to the case.Edit 13aug2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 18aug2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 20-sep-2021: additional information was received from initial reporting consumer on (b)(6) 2021.Added two medical histories of high blood fat, prolapse of gastric mucosa.Added lab test results for blood glucose.Added two humapens ergo ii as suspect.Added eight non serious events of cataract, vision blurred, sweating, sleepy, headache, blood sugar fluctuation, blood sugar abnormal and product dose omission.Updated narrative accordingly to reflect changes.Update 22-sep-2021: additional information received from initial reporter on (b)(6) 2021.Added a medical history of high blood lipid and new dosage regimens of insulin lispro protamine suspension 75%/insulin lispro 25% treatment.Added two non-serious events of injection site pain and injection site bleeding.Updated relatedness summary and narrative with new information.Edit 23-sep-2021: upon review of information received on 16-sep-2021, updated relatedness summary in narrative.No other changes were made to the case.Update 28sep2021:additional information received on 22sep2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information, the european and canadian (eu/ca) device information, malfunction from unknown to no, and device return status to returned to manufacturer.Added date of manufacturer and date returned to manufacturer for the suspect humapen ergo ii ( lot number 1609d01) associated with product complaint number (b)(4) which was returned to the manufacturer.Corresponding fields and narrative updated accordingly.Edit 06oct2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.

• Brand Name: HUMAPEN ERGO II
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 12360330
• MDR Text Key: 268203904
• Report Number: 1819470-2021-00100
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9557
• Device Lot Number: 1609D01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Date Manufacturer Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 80 YR
• Patient Weight: 55