MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA HALF-DOSE PEN; FOR TREATMENT PURPOSES

ELI LILLY AND COMPANY HUMAPEN LUXURA HALF-DOSE PEN; FOR TREATMENT PURPOSES

Model Number MS9673A

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Flow or Under Infusion (2182); Failure to Deliver (2338); Mechanical Jam (2983); Output Problem (3005)

Patient Problems Hypoglycemia (1912); Syncope/Fainting (4411)

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.

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 40-year-old female (at the time of the report) patient of unspecified origin.Medical history included born prematurely, four autoimmune diseases, celiac disease, hashimoto disease, numerous unspecified allergies and type 1 diabetes, diabetes since 2006.Historical drugs included insulin glargine and insulin degludec.Concomitant medications included insulin glargine (lantus), chromium, levocarnitine and pyridoxine hydrochloride for unknown indication.The patient received insulin lispro (rdna origin) (humalog 100 u/ml) from a cartridge via a reusable pen (humapen luxura hd), for the treatment of type 1 diabetes mellitus.She also took insulin glargine (rdna origin) (abasaglar 100 u/ml) from a cartridge, for the treatment of type 1 diabetes mellitus.Dose regimen and the start dates were not provided.Since an unknown date, she developed damage in her thyroid gland and she was hospitalized many times due to this on an unknown dates.It was reported that the first hospitalization was in 2014.After the thyroid crises (damage), she fought overweight; she had gained 20 kilograms in three weeks.The event of gained weight was considered as serious by the company due to medically significant reasons.By (b)(6) 2021, she had had a humapen luxura hd pen that was five years old, and since an unknown date it had not been working properly, it jammed and sometimes did not give insulin (pc (b)(4); lot 1401g10).Her insulin doses were very important to her, and she was dosing every half unit because she required a half of unit for her evening and night doses.It was not fun for her neither eating in the morning nor having her blood glucose levels at about 30 mg/dl (as reported).The event of hypoglycemia was considered as serious by the company due to medically significant reasons.It was very difficult for her to control her blood glucose levels, because in the morning one unit of insulin lowered them by 20 mg / dl, and in the evening one unit lowered them by as much as 100 mg / dl.Furthermore at 140 mg / dl, she would not fall asleep, but with hypoglycemia, she would wake up from her sleep.Since an unknown date, she had was severely hypoglycemic.Humapen luxura hd device did not always jam and in general she had hypoglycemia of 30 mg /dl after the administration of one unit, which was why the half-pen was so important to her to administer half unit.Usually, if she exercised in the evening and had a sugar of 170 mg / dl and gave herself one unit at night the sugar would drop to 50 mg / dl.If she gave 0.5 units, the sugar would drop to 70-80 mg / dl.She would like not to have to eat the third dinner.This week (first week of (b)(6) 2021) she had a 12-hour night shift, and after intensive work at 2 am, she had a sugar level of 46 mg / dl- no relatedness stated for insulins use.The diabetics were nervous, they could be rude, aggressive because when they have very low blood sugar levels they get panic attacks.She herself had a hypoglycemic panic attack because the brain gets the signal that it is dying.She concluded that she had the old pen since spring 2015.Insulin lispro always worked on her for exactly three hours.On (b)(6) 2021 (this morning at 8:50) she gave insulin lispro and she was fine, and at 12:40 she felt sick and had sugar of 260 mg / dl (she had no time to inject insulin).In the past, she used to have a dose of insulin glargine spread over twice a day, but at 3-4 p.M.She had to eat something (there were no peaks).That time she was thinner and took 15 units at 10 p.M.And 5 units around 6 am.After insulin lispro there were peaks every three hours.Now she took 16 units of insulin glargine for the night, but for example she happened to have a sugar of 400 mg / dl after midnight because she ate cheese late, and she could eat protein and fats only until 2 p.M., because then after midnight sugar grows very fast.She developed hyperglycemia due to mental stress.She could have sugar of 400 mg / dl out of anger.She used to go to an interview for a job, but earlier she had an argument with a friend.She had high blood sugar, she administered insulin lispro, after 1.5 hours at a job interview, she fainted because she did not take into account that high sugar drops faster as a result of stress and she gave too much insulin.The events of blood glucose decreased and faint were considered as serious by company due to their medically significance.All the time she had a glycated hemoglobin level of around 8.After 16 years of illness, the ophthalmologist assessed that she had no diabetic changes related to her eyesight, although she thought that her vision was worse.Information regarding a corrective treatment and the outcome of the events was not provided.Insulin lispro and insulin glargine treatment status was not provided.The patient was the operator of the humapen luxura hd devices and her training status was not provided.The humapen luxura hd pen model duration of use was five years (improper use).The reported suspect humapen luxura hd device (first device) duration of use was five years.The suspect humapen luxura hd device duration of use for second humapen luxura device was unknown.The first humapen luxura hd with pc (b)(4) was returned to the manufacturer on 15apr2021.The return status of second suspect device was not provided.The reporting consumer did not provide an assessment of relatedness between the events and insulin lispro or insulin glargine treatment and suspect device.Edit 01-apr-2021: upon review of the initial information received on (b)(6) 2021, updated coding of suspect humapen luxura hd to match model for lot number, and the formulation of insulin glargine to cartridge; in addition information regarding improper use of humapen luxura hd was noted.Also, updated eu/ca fields indicating that device did not represent a threat of public health and the information about in which countries the device is distributed.Added details regarding the event of hypoglycemia and the impact of insulin doses in her blood glucose levels.Updated narrative accordingly.Edit 05apr2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 14-apr-2021: additional information was received from the initial reporting consumer on 08-apr-2021.Added two serious events of blood glucose decreased and faint.Added seven non-serious events of stress, panic attack, feeling sick, blood glucose increased, inappropriate schedule of drug administration, glycosylated hemoglobin increased and hyperglycemia.Added one suspect humapen luxura hd device.Updated coding of insulin glargine from insulin glargine to abasaglar.Added dosage regimen of insulin lispro and insulin glargine, added lab test.Updated narrative with new information.Update 22apr2021: opened case in error.Update 28apr2021: additional information received on 22apr2021 from the global product complaint database.Added date of return of the device associated with pc (b)(4).Corresponding fields and narrative updated accordingly.Edit 30-apr-2021: upon review of the information received on (b)(6) 2021, the improper use and storage and device age was corrected for the humapen luxura hd (lot# 1709g03).No other changes were done to the case.Edit 06may2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.

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 40-year-old female (at the time of the report) patient of unspecified origin.Medical history included born prematurely, four autoimmune diseases, celiac disease, hashimoto disease, numerous unspecified allergies and type 1 diabetes, diabetes since 2006.Historical drugs included insulin glargine and insulin degludec.Concomitant medications included insulin glargine (lantus), chromium, levocarnitine and pyridoxine hydrochloride for unknown indication.The patient received insulin lispro (rdna origin) (humalog 100 u/ml) from a cartridge via a reusable pen (humapen luxura hd), for the treatment of type 1 diabetes mellitus.She also took insulin glargine (rdna origin) (abasaglar 100 u/ml) from a cartridge, for the treatment of type 1 diabetes mellitus.Dose regimen and the start dates were not provided.Since an unknown date, she developed damage in her thyroid gland and she was hospitalized many times due to this on an unknown dates.It was reported that the first hospitalization was in 2014.After the thyroid crises (damage), she fought overweight; she had gained 20 kilograms in three weeks.The event of gained weight was considered as serious by the company due to medically significant reasons.By mar-2021, she had had a humapen luxura hd pen that was five years old, and since an unknown date it had not been working properly, it jammed and sometimes did not give insulin (pc 5522077; lot 1401g10).Her insulin doses were very important to her, and she was dosing every half unit because she required a half of unit for her evening and night doses.It was not fun for her neither eating in the morning nor having her blood glucose levels at about 30 mg/dl (as reported).The event of hypoglycemia was considered as serious by the company due to medically significant reasons.It was very difficult for her to control her blood glucose levels, because in the morning one unit of insulin lowered them by 20 mg / dl, and in the evening one unit lowered them by as much as 100 mg / dl.Furthermore at 140 mg / dl, she would not fall asleep, but with hypoglycemia, she would wake up from her sleep.Since an unknown date, she had was severely hypoglycemic.Humapen luxura hd device did not always jam and in general she had hypoglycemia of 30 mg /dl after the administration of one unit, which was why the half-pen was so important to her to administer half unit.Usually, if she exercised in the evening and had a sugar of 170 mg / dl and gave herself one unit at night the sugar would drop to 50 mg / dl.If she gave 0.5 units, the sugar would drop to 70-80 mg / dl.She would like not to have to eat the third dinner.This week (first week of (b)(6) 2021) she had a 12-hour night shift, and after intensive work at 2 am, she had a sugar level of 46 mg / dl- no relatedness stated for insulins use.The diabetics were nervous, they could be rude, aggressive because when they have very low blood sugar levels they get panic attacks.She herself had a hypoglycemic panic attack because the brain gets the signal that it is dying.She concluded that she had the old pen since spring 2015.Insulin lispro always worked on her for exactly three hours.On (b)(6) 2021 (this morning at 8:50) she gave insulin lispro and she was fine, and at 12:40 she felt sick and had sugar of 260 mg / dl (she had no time to inject insulin).In the past, she used to have a dose of insulin glargine spread over twice a day, but at 3-4 p.M.She had to eat something (there were no peaks).That time she was thinner and took 15 units at 10 p.M.And 5 units around 6 am.After insulin lispro there were peaks every three hours.Now she took 16 units of insulin glargine for the night, but for example she happened to have a sugar of 400 mg / dl after midnight because she ate cheese late, and she could eat protein and fats only until 2 p.M., because then after midnight sugar grows very fast.She developed hyperglycemia due to mental stress.She could have sugar of 400 mg / dl out of anger.She used to go to an interview for a job, but earlier she had an argument with a friend.She had high blood sugar, she administered insulin lispro, after 1.5 hours at a job interview, she fainted because she did not take into account that high sugar drops faster as a result of stress and she gave too much insulin.The events of blood glucose decreased and faint were considered as serious by company due to their medically significance.All the time she had a glycated hemoglobin level of around 8.After 16 years of illness, the ophthalmologist assessed that she had no diabetic changes related to her eyesight, although she thought that her vision was worse.Information regarding a corrective treatment and the outcome of the events was not provided.Insulin lispro and insulin glargine treatment status was not provided.The patient was the operator of the humapen luxura hd devices and her training status was not provided.The humapen luxura hd pen model duration of use was five years (improper use).The reported suspect humapen luxura hd device (first device) duration of use was five years.The suspect humapen luxura hd device duration of use for second humapen luxura device was unknown.The first humapen luxura hd with pc 5522077 was returned to the manufacturer on 15apr2021.The return status of second suspect device was not provided.The reporting consumer did not provide an assessment of relatedness between the events and insulin lispro or insulin glargine treatment and suspect device.Edit 01-apr-2021: upon review of the initial information received on 24-mar-2021, updated coding of suspect humapen luxura hd to match model for lot number, and the formulation of insulin glargine to cartridge; in addition information regarding improper use of humapen luxura hd was noted.Also, updated eu/ca fields indicating that device did not represent a threat of public health and the information about in which countries the device is distributed.Added details regarding the event of hypoglycemia and the impact of insulin doses in her blood glucose levels.Updated narrative accordingly.Edit 05apr2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 14-apr-2021: additional information was received from the initial reporting consumer on 08-apr-2021.Added two serious events of blood glucose decreased and faint.Added seven non-serious events of stress, panic attack, feeling sick, blood glucose increased, inappropriate schedule of drug administration, glycosylated hemoglobin increased and hyperglycemia.Added one suspect humapen luxura hd device.Updated coding of insulin glargine from insulin glargine to abasaglar.Added dosage regimen of insulin lispro and insulin glargine, added lab test.Updated narrative with new information.Update 22apr2021: opened case in error.Update 28apr2021: additional information received on 22apr2021 from the global product complaint database.Added date of return of the device associated with pc 5522077.Corresponding fields and narrative updated accordingly.Edit 30-apr-2021: upon review of the information received on 08-apr-2021, the improper use and storage and device age was corrected for the humapen luxura hd (lot# 1709g03).No other changes were done to the case.Edit 06may2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 10may2021: additional information received on 10may2021 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 added the date of manufacture for the suspect device associated with pc 5522077.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 statement dated 10may2021 in the b.5.Field.No further follow up is planned.Evaluation summary a female patient reported that her humapen luxura hd device jammed and sometimes did not give insulin.She also stated that the device did not always jam.The patient experienced hypoglycemia.Investigation of the returned device (batch number 1401g01, manufactured january 2014) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.The patient reportedly used the device for five years.The core instructions for use state the humapen luxura hd is designed to be used for up to three years after first use.There is evidence of improper use.The patient used the device beyond its approved use life.As the device met functional and dose accuracy requirements, it is unlikely that this misuse is relevant to the complaint or the event hypoglycemia.

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Brand Name

HUMAPEN LUXURA HALF-DOSE PEN

Type of Device

FOR TREATMENT PURPOSES

Manufacturer (Section D)

ELI LILLY AND COMPANY

lilly corporate center

indianapolis IN 46285

MDR Report Key

11615867

MDR Text Key

260759485

Report Number

1819470-2021-00050

Device Sequence Number

Product Code

FMF

UDI-Device Identifier

00300029673019

UDI-Public

00300029673019

Combination Product (y/n)

PMA/PMN Number

K100988

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

consumer,foreign

Type of Report

Initial,Followup,Followup

Report Date

06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

04/05/2021

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Lay User/Patient

Device Model Number

MS9673A

Device Catalogue Number

MS9673

Device Lot Number

1401G10

Was Device Available for Evaluation?

Yes

Date Returned to Manufacturer

04/15/2021

Date Manufacturer Received

05/10/2021

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Patient Outcome(s)

Other;

Patient Age

40 YR

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA HALF-DOSE PEN; FOR TREATMENT PURPOSES

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