MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA BURGUNDY; FOR TREATMENT PURPOSES

Model Number MS9662

Device Problems Difficult or Delayed Activation (2577); Mechanical Jam (2983)

Patient Problem Hyperglycemia (1905)

Event Date 08/31/2021

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.

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) asian female patient.Medical history included hyperlipidemia.Concomitant medications included oral hypoglycemic agent and acarbose for type ii diabetes and voglibose and vildagliptin for diabetes mellitus.The patient received insulin lispro (rdna origin) injections (humalog 100 u/ml) via an unknown formulation 16 units, night 16 units twice daily subcutaneously for the treatment of type ii diabetes mellitus beginning in 2014.In addition, she received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix 25) from cartridge via reusable pen device (humapen luxura burgundy), subcutaneously, 20 units in the morning and 20 units in the night (twice daily) for the treatment of diabetes mellitus beginning on an unknown date in 2015.On an unspecified date in 2016, while in insulin lispro treatment, she had a cardiac stenting procedure because the heart was not good.The event of heart was not good considered serious due to medically significant reason.Since 2019, she had situations of ears were not good, and did not remember things.On an unknown date, her blood glucose was very unstable and it was often high some time ago (specific time was not provided).So, she followed the doctors advice to change the injection dose of the insulin from morning 16 units, night 16 units to morning 20 units, night 20 units, the blood glucose was controlled slightly stable, so the she changed the injection dose of the insulin by self from morning 20 units, night 20 units to morning 18 units, night 18 units.She was also got more and more fat after using the insulin; she was (b)(6) and gained to (b)(6).On an unknown date in (b)(6) 2021, she was hospitalized due to always high blood glucose and blood glucose regulating.No further information regarding hospitalization was reported.On an unknown date in (b)(6)2021, after hospitalization, she received dulaglutide (trulicity), unknown dose weekly, subcutaneously for treatment of diabetes mellitus.On an unknown date, she could not see clearly.On an unknown date, her humapen luxura injection button could not be pressed down ((b)(4), lot number: unknown).No further information provided.Information regarding further corrective treatments and outcome of events was not reported.Insulin lispro, insulin lispro protamine suspension 75%/insulin lispro 25% and dulaglutide therapy was continued.Patient was the operator of humapen luxura burgundy and her training status was not provided.The general humapen luxura model duration of use was unknown.Suspect humapen luxura duration of use was six years.Action taken with the suspect device was not provided and its return was not expected.The reporting consumer did not provide the relatedness between events and insulin lispro treatment, insulin lispro protamine suspension 75%/insulin lispro 25% and dulaglutide therapy or humapen luxura burgundy.Update 02-sep-2021: additional information received from initial consumer reporter and secondary reporter on 31-aug-2021 and 01-sep-2021 via psp was processed together.Added second consumer reporter, two concomitant medications, two suspect drugs and one suspect device, one serious event of blood sugar increased and its laboratory test and one non serious event of visual impairment.Updated weight of the patient, outcome of the event of weight gain as recovering.Updated case and narrative with new information.Edit 08sep2021: updated medwatch and european and canadian (eu/ca) 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 30sep2021 in the b.5.Field.No further follow-up is planned.Evaluation summary: a female patient reported that the injection button of her humapen luxura device could not be pressed down.She experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen luxura devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.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 solicited case, reported by a consumer via a patient support program (psp), concerned a 70-year old asian female patient.Medical history included hyperlipidemia.Concomitant medications included oral hypoglycemic agent and acarbose for type ii diabetes and voglibose and vildagliptin for diabetes mellitus.The patient received insulin lispro (rdna origin) injections (humalog 100 u/ml) via an unknown formulation 16 units, night 16 units twice daily subcutaneously for the treatment of type ii diabetes mellitus beginning in 2014.In addition, she received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix 25) from cartridge via reusable pen device (humapen luxura burgundy), subcutaneously, 20 units in the morning and 20 units in the night (twice daily) for the treatment of diabetes mellitus beginning on an unknown date in 2015.On an unspecified date in 2016, while in insulin lispro treatment, she had a cardiac stenting procedure because the heart was not good.The event of heart was not good considered serious due to medically significant reason.Since 2019, she had situations of ears were not good, and did not remember things.On an unknown date, her blood glucose was very unstable and it was often high some time ago (specific time was not provided).So, she followed the doctors advice to change the injection dose of the insulin from morning 16 units, night 16 units to morning 20 units, night 20 units, the blood glucose was controlled slightly stable, so the she changed the injection dose of the insulin by self from morning 20 units, night 20 units to morning 18 units, night 18 units.She was also got more and more fat after using the insulin; she was 60kg and gained to 67kg.On an unknown date in (b)(6) 2021, she was hospitalized due to always high blood glucose and blood glucose regulating.No further information regarding hospitalization was reported.On an unknown date in (b)(6)2021, after hospitalization, she received dulaglutide (trulicity), unknown dose weekly, subcutaneously for treatment of diabetes mellitus.On an unknown date, she could not see clearly.On an unknown date, her humapen luxura injection button could not be pressed down (pc number: (b)(4), lot number: unknown).No further information provided.Information regarding further corrective treatments and outcome of events was not reported.Insulin lispro, insulin lispro protamine suspension 75%/insulin lispro 25% and dulaglutide therapy was continued.Patient was the operator of humapen luxura burgundy and her training status was not provided.The general humapen luxura model duration of use was unknown.Suspect humapen luxura duration of use was six years.Action taken with the suspect device was not provided.The suspect humapen luxura (unknown lot) device associated with product complaint (b)(4) was not returned to the manufacturer.The reporting consumer did not provide the relatedness between events and insulin lispro treatment, insulin lispro protamine suspension 75%/insulin lispro 25% and dulaglutide therapy or humapen luxura burgundy.Update 02-sep-2021: additional information received from initial consumer reporter and secondary reporter on 31-aug-2021 and 01-sep-2021 via psp was processed together.Added second consumer reporter, two concomitant medications, two suspect drugs and one suspect device, one serious event of blood sugar increased and its laboratory test and one non serious event of visual impairment.Updated weight of the patient, outcome of the event of weight gain as recovering.Updated case and narrative with new information.Edit 08sep2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 30sep2021:additional information received on 27sep2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information for the suspect humapen luxura (unknown lot) device associated with product complaint (b)(4) which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

This device was associated with an increased blood glucose on an unknown date in (b)(6)2021 and (b)(6) 2022.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a 70-year old asian female patient.Medical history included hyperlipidemia and daughter had diabetes mellitus.Concomitant medications included oral hypoglycemic agent and acarbose for type ii diabetes and voglibose, repaglinide, metformin and vildagliptin all for diabetes mellitus.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna) injections (humalog mix50), via an unknown formulation 23 units in morning and 9 units at night twice daily subcutaneously for the treatment of type ii diabetes mellitus beginning about in 2012.She also received insulin lispro (rdna origin) injections (humalog 100 u/ml) via an unknown formulation 16 units, night 16 units twice daily subcutaneously for the treatment of type ii diabetes mellitus beginning in 2014.In addition, she received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog mix 25) from cartridge via reusable pen device (humapen luxura burgundy), subcutaneously, 20 units in the morning and 20 units in the night (twice daily) for the treatment of diabetes mellitus beginning on an unknown date in 2015.On an unspecified date in 2016, while in insulin lispro treatment, she had a cardiac stenting procedure because the heart was not good.The event of heart was not good considered serious due to medically significant reason.Since 2019, she had situations of ears were not good, and did not remember things.On an unknown date, her blood glucose was very unstable and it was often high some time ago (specific time was not provided).So, she followed the doctors advice to change the injection dose of the insulin from morning 16 units, night 16 units to morning 20 units, night 20 units, the blood glucose was controlled slightly stable, so the she changed the injection dose of the insulin by self from morning 20 units, night 20 units to morning 18 units, night 18 units.She was also got more and more fat after using the insulin; she was 60kg and gained to 67kg.On an unknown date in (b)(6) 2021, she was hospitalized due to always high blood glucose and blood glucose regulating.No further information regarding hospitalization was reported.On an unknown date in (b)(6) 2021, after hospitalization, she received dulaglutide (trulicity), unknown dose weekly, subcutaneously for treatment of diabetes mellitus.On an unknown date, she could not see clearly.On an unknown date, her humapen luxura injection button could not be pressed down (pc number: (b)(4), lot number: unknown).She was hospitalized many times (the specific time and situation were not provided).On an unknown date in (b)(6) 2022, she was hospitalized due to high blood glucose (units, values and reference range were not provided).On an unknown date in (b)(6) 2022, she was hospitalized due to poor heart and cardiac stent surgery.In (b)(6) 2022, she was hospitalized due to urticaria might be caused by dulaglutide allergy (captured in lss (b)(4)), followed the doctor advice to stop dulaglutide after hospitalization.Her original blood glucose control was not very good, but it was passable, but the blood glucose had been very high, which was a high-risk blood glucose.The blood glucose was so high that was scary, it was too high and caused the burden in the heart was too heavy, everything was not good.Her weight was overweight, 65 kg.Information regarding further corrective treatments and outcome of events was not reported.Insulin lispro, insulin lispro protamine suspension 75%/insulin lispro 25% and insulin lispro protamine suspension 50%/insulin lispro 50%therapy was continued.The dulaglutide was discontinued on an unknown date in (b)(6) 2022.Patient was the operator of humapen luxura burgundy and her training status was not provided.The general humapen luxura model duration of use was unknown.Suspect humapen luxura duration of use was six years.Action taken with the suspect device was not provided.The suspect humapen luxura (unknown lot) device associated with product complaint (b)(4) was not returned to the manufacturer.The reporting consumer did not provide the relatedness between events and insulin lispro treatment, insulin lispro protamine suspension 75%/insulin lispro 25%, insulin lispro protamine suspension 50%/insulin lispro 50% and dulaglutide therapy or humapen luxura burgundy.Update (b)(6) 2021: additional information received from initial consumer reporter and secondary reporter on (b)(6) 2021 and (b)(6) 2021 via psp was processed together.Added second consumer reporter, two concomitant medications, two suspect drugs and one suspect device, one serious event of blood sugar increased and its laboratory test and one non serious event of visual impairment.Updated weight of the patient, outcome of the event of weight gain as recovering.Updated case and narrative with new information.Edit 08sep2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 30sep2021:additional information received on 27sep2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information for the suspect humapen luxura (unknown lot) device associated with product complaint (b)(4) which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.Update 26-apr-2022: additional information was received from the initial consumer reporter via the psp on (b)(6) 2022.Added one medical history, two concomitant medications, additional suspect drug of insulin lispro protamine suspension 50%/insulin lispro 50%, added two serious events of blood glucose increased and cardiac disorder (hospitalization criteria), added event onset in the first episode of cardiac disorder.Updated narrative with new information.Edit 02may2022: updated medwatch fields for expedited device reporting.No new information added.

• Brand Name: HUMAPEN LUXURA BURGUNDY
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): PHILLIPS-MEDISIZE CORPORATION; medical device manufacturing; 415 red cedar street; menomonie WI 54751
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 12475658
• MDR Text Key: 281016883
• Report Number: 1819470-2021-00120
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K142518
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9662
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: No
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian