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

Model Number MS9557

Device Problems Loose or Intermittent Connection (1371); Mechanical Jam (2983); Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 01/31/2019

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 female patient of unknown age and origin.Medical history included that she was hospitalized in 2010 and it was found that diabetes had caused complications like fundus retinal macular degeneration, poor vision, it was blurry when she saw things, vision to 0.25 (unit not provided) and her eyes were always uncomfortable.Concomitant medications were not provided.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30), from a cartridge, via a reusable pen, humapen ergo ii, 18 units each morning and 14 units each night, twice a day, subcutaneously for the treatment of diabetes mellitus, beginning in 2010.In 2017 or 2018, while on human insulin isophane suspension 70%/human insulin 30%, she experienced unstable blood glucose, sometimes the blood glucose was high, sometimes the blood glucose was low, the blood glucose was suddenly high and suddenly low (values, units and reference range was not provided), due to which she was hospitalized for treatment and as per advice of doctor, was switched to using insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog mix 50), twice a day, 16 units in the morning, 12 units in the evening, subcutaneously for the treatment of diabetes mellitus.Her doctor had told to change dose of insulin lispro protamine suspension 50%/insulin lispro 50% according to blood glucose where she could adjust up and down by 2 units.But after starting insulin lispro protamine suspension 50%/insulin lispro 50%, blood glucose control was not good and blood glucose fluctuations were relatively large: when blood glucose was high, it was high as 10-20 (unit not provided) and there also was hypoglycemia.According to the change of blood glucose value, she increased her insulin lispro protamine suspension 50%/insulin lispro 50% dose from 16 units in the morning and 12 units in the evening to 18 units (dosing frequency was not provided).In 2019, due to problem of the injection pen (humapen ergo ii), the injection button could not be pressed, there was no clicking sound.She adjusted dose by regulating plugs on her own, but she did not press the injection button and did not inject the correct dose into the body.Besides that, the screw thread of the cartridge holder (which connected to the pen body) could not be screwed onto the pen body, it was slipping and very loose ((b)(4)/ lot #0902d04).She was also hospitalized for treatment due to poor blood glucose control, regulated blood glucose, had her eyes checked and went to the ophthalmology.On an unknown date, while on human insulin isophane suspension 70%/human insulin 30% and insulin lispro protamine suspension 50%/insulin lispro 50% therapies, she had high blood lipids and sometimes had high blood pressure, blood pressure value as high as 160 (unit not provided).Event of blood pressure value as high as 160 was considered to be serious by the company due to medically significant reason.Sometimes when injecting with an injection pen, the needle inserted into her skin and inserted into the non-absorbing place, and would be painful during the injection.After using lilly products (names not specified), the symptoms of retinal macular degeneration had aggravated.Suddenly her eyes were blurry, for example she could not see the calibration of the injection pen clearly, the fonts on the television were deformed and could not distinguish between black and white color.Information regarding corrective treatment and outcome of events was not provided.Treatment status of insulin lispro protamine suspension 50%/insulin lispro 50% was ongoing.Follow up was not possible as reporter was not willing to be contacted for follow up and treating physician contact details was not provided.The patient was operator of humapen ergo ii device and her training status was not provided.The model and suspect device duration of use was not provided, but it was started in 2010.The action taken with suspect device was not provided but its return was expected.The reporting consumer did not know relatedness for the events with human insulin isophane suspension 70%/human insulin 30% and insulin lispro protamine suspension 50%/insulin lispro 50% therapies and did not provide relatedness of events with humapen ergo ii device.Edit 01dec2022: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.

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.

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 female patient of unknown age and origin.Medical history included that she was hospitalized in 2010 and it was found that diabetes had caused complications like fundus retinal macular degeneration, poor vision, it was blurry when she saw things, vision to 0.25 (unit not provided) and her eyes were always uncomfortable.Concomitant medications were not provided.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30), from a cartridge, via a reusable pen, humapen ergo ii, 18 units each morning and 14 units each night, twice a day, subcutaneously for the treatment of diabetes mellitus, beginning in 2010.In 2017 or 2018, while on human insulin isophane suspension 70%/human insulin 30%, she experienced unstable blood glucose, sometimes the blood glucose was high, sometimes the blood glucose was low, the blood glucose was suddenly high and suddenly low (values, units and reference range was not provided), due to which she was hospitalized for treatment and as per advice of doctor, was switched to using insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog mix 50), twice a day, 16 units in the morning, 12 units in the evening, subcutaneously for the treatment of diabetes mellitus.Her doctor had told to change dose of insulin lispro protamine suspension 50%/insulin lispro 50% according to blood glucose where she could adjust up and down by 2 units.But after starting insulin lispro protamine suspension 50%/insulin lispro 50%, blood glucose control was not good and blood glucose fluctuations were relatively large: when blood glucose was high, it was high as 10-20 (unit not provided) and there also was hypoglycemia.According to the change of blood glucose value, she increased her insulin lispro protamine suspension 50%/insulin lispro 50% dose from 16 units in the morning and 12 units in the evening to 18 units (dosing frequency was not provided).In 2019, due to problem of the injection pen (humapen ergo ii), the injection button could not be pressed, there was no clicking sound.She adjusted dose by regulating plugs on her own, but she did not press the injection button and did not inject the correct dose into the body.Besides that, the screw thread of the cartridge holder (which connected to the pen body) could not be screwed onto the pen body, it was slipping and very loose (pc # (b)(4) / lot #0902d04).She was also hospitalized for treatment due to poor blood glucose control, regulated blood glucose, had her eyes checked and went to the ophthalmology.On an unknown date, while on human insulin isophane suspension 70%/human insulin 30% and insulin lispro protamine suspension 50%/insulin lispro 50% therapies, she had high blood lipids and sometimes had high blood pressure, blood pressure value as high as 160 (unit not provided).Event of blood pressure value as high as 160 was considered to be serious by the company due to medically significant reason.Sometimes when injecting with an injection pen, the needle inserted into her skin and inserted into the non-absorbing place, and would be painful during the injection.After using lilly products (names not specified), the symptoms of retinal macular degeneration had aggravated.Suddenly her eyes were blurry, for example she could not see the calibration of the injection pen clearly, the fonts on the television were deformed and could not distinguish between black and white color.Information regarding corrective treatment and outcome of events was not provided.Treatment status of insulin lispro protamine suspension 50%/insulin lispro 50% was ongoing.Follow up was not possible as reporter was not willing to be contacted for follow up and treating physician contact details was not provided.The patient was operator of humapen ergo ii device and her training status was not provided.The model and suspect device duration of use was not provided, but it was started in 2010.The action taken with suspect device was not provided but it returned to manufacturer.The reporting consumer did not know relatedness for the events with human insulin isophane suspension 70%/human insulin 30% and insulin lispro protamine suspension 50%/insulin lispro 50% therapies and did not provide relatedness of events with humapen ergo ii device.Edit 01dec2022: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 19dec2022: additional information received on 13dec2022 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields, malfunction from unknown to no, and device return status to returned to manufacturer; and added the date of manufacture and date returned to manufacturer for the suspect humapen ergo ii associated with (b)(4).Corresponding fields and narrative updated accordingly.

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 19dec2022 in the b.5.Field.No further follow-up is planned.Evaluation summary: a female patient reported that in 2019, the injection button of her humapen ergo ii device could not be pressed, there was no clicking sound.In addition, "the screw thread of the cartridge holder (which connected to the pen body) could not be screwed onto the pen body, it was slipping and very loose." she experienced blood glucose fluctuation and inadequate control of diabetes mellitus.The investigation of the returned device (batch 0902d04, manufactured february 2009) found the pen housing was cracked and the soft touch was partly de-bonded, with evidence of excessive force observed for these issues.However, the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.The patient reported that the device had been used since 2010.The core instructions for use state the humapen ergo ii has been designed to be used for up to 3 years after first use.In addition, the patient reported vision issues, including that she could not see the calibration of the injection pen clearly.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 damage to the device is consistent with damage while in the field, and the patient used the device beyond its approved use life.These misuses are not likely relevant to the events of blood glucose fluctuation and inadequate control of diabetes mellitus since the device met functional requirements and met dose accuracy and glide (injection) force specifications.In addition, the patient used the device while visually impaired.It is unknown if this misuse is relevant to the events.

• 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): TECH GROUP NORTH AMERICA INC. DBA WEST; 640 south rockford drive; tempe AZ 85281
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 15895504
• MDR Text Key: 304631254
• Report Number: 1819470-2022-00095
• 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: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 0902D04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 12/01/2022
• Supplement Dates Manufacturer Received: 12/13/2022
• Supplement Dates FDA Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2009
• 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 Sex: Female