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

Model Number MS9673A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Hyperglycemia (1905); Underdose (2542)

Event Date 08/12/2019

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 compliant: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) (at the time of initial report) male patient of unknown origin.Medical history included historical medication insulin human for unknown indication.Concomitant medications included unspecified vitamin b12 for anemia and calcium deficiency and immuguard (as reported), taken as immune stimulant.The patient received insulin lispro (rdna origin) (humalog) from an unknown formulation via reusable pen device (humapen luxura half dose), with a 3.5 units in the morning, 4.5 units or 5 units in the mid-day (lunch) and 2.5 units or 3.5 units in the night, subcutaneously for the treatment of diabetes mellitus beginning on an unknown date in (b)(6) 2019.On approximately (b)(6) 2019 or (b)(6) 2019, the injection button of first humapen luxura half dose device was not stuck in its place it seemed like it was dislocated (pc number 4799274 and lot number unknown).There were three to four drops on the needle after giving the dose they assumed that it was not taking his accurate dose.On approximately (b)(6)2019, he experienced increased blood glucose and as it reached 400 mg/dl although it was 60 mg/dl when he started the therapy (units and range were not provided).Outcome for the events was not recovered.Approximately, on (b)(6) 2019, the injection button of humapen luxura hd (second device) was not stuck on its place and it seemed like it would be dislocated (pc no 4848352 and lot no 1801g01).His mother always found that there was all insulin on his arms after he had his dose although increasing his doses and counting from one to ten before the pen was removed.Therefore, it was assumed that he was not taking his accurate dose.Although when he started insulin lispro therapy his blood glucose was 60 mg/dl but since (b)(6) 2019, his blood glucose level was high and it reached 600 mg/dl.The event of blood glucose increased (second episode) was considered as serious by the company due to medically significant reason.On (b)(6) 2019, he was recovered from blood glucose increased (second episode) and incorrect dose administered (second episode).As of (b)(6) 2019, he was taking his insulin doses by insulin syringe and his blood glucose level was adjusted at morning 80 mg/dl and measured after that was 240 mg/dl.Information regarding the corrective treatment was unknown.Insulin lispro therapy was ongoing.The operator of both humapen luxura half dose was mother of patient and her training status was not provided.The general model duration use for humapen luxura hd was around two months.The first suspect humapen luxura hd duration of use for was six or seven days.The second suspect humapen luxura hd duration of use was around two months.The use of the suspect devices were ongoing and their return status was expected.The initial reporting consumer did not relate the event of incorrect dose administered (first episode) with the insulin lispro therapy but related it with humapen luxura hd (first pen).The initial reporting consumer did not know the relatedness between the event of blood glucose increased (first episode) with insulin lispro therapy and with the humapen luxura hd (first pen).The initial reporting consumer did not relate the event of blood glucose increased (second episode) with insulin lispro therapy and related the event of incorrect dose administered (second episode) with insulin lispro therapy.The initial reporting consumer related the events of blood glucose increased (second episode) and incorrect dose administered (second episode) with humapen luxura hd (second pen).Update (b)(6) 2019: additional information was received from initial reporting consumer via a psp on (b)(6) 2019.This case was upgraded to serious due to addition of two serious events of blood glucose increased (second episode) and blood glucose decreased.Added: one non- serious event of incorrect dose administered (second episode), one suspect reusable device of humapen luxura hd, three laboratory tests of blood glucose, historical medication of insulin human for unknown indication and eu/ca fields of second suspect device.Updated: dosage regimen of humalog.Upon review of information received on (b)(6) 2019, updated the first suspect device from humapen luxura unknown body type to humapen luxura hd, corrected the as reported causality of event incorrect dose administered from yes to no (not related) and product complaint was re-processed for first suspect device.Causality statement, device paragraph and narrative was updated with new information accordingly.Edit (b)(6) 2019: per affiliate review of information received on (b)(6) 2019, updated laboratory test result of 24 mg/dl to 240 mg/dl; deleted serious event of blood glucose decreased and updated description of non-serious event of blood glucose increased.Updated narrative accordingly.Edit (b)(6) 2019: upon review of information received on (b)(6) 2019, updated the model numbers of both humapen luxura hd pens and no other changes were made in the case.Edit (b)(6) 2019: upon review of information received on (b)(6) 2019, updated general model duration use for humapen luxura hd in device paragraph, narrative was updated with pc number 4848352 and moved the pc citation behind the complaint description.No other changes were made in the case.Edit (b)(6) 2019: updated medwatch fields for expedited device reporting.No new information added.Edit (b)(6) 2019: updated medwatch fields for expedited device reporting, unique identifier number.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 statement dated 10sep2019 in the b.5.Field.No further follow up is planned.Evaluation summary: the mother of a male patient reported that the injection button of her son's humapen luxura hd device "was not stuck on its place and it seemed like it would be dislocated." his mother always found that there was insulin on his arms after he had his dose.Therefore, it was assumed that he was not getting his accurate dose.The patient experienced increased blood glucose levels.The device was not returned to the manufacturer for investigation (batch number 1801g01, manufactured january 2018).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review for the device batch did not identify any atypical findings with regard to dose accuracy, device broken, or unspecified pen leaking issues.All humapen luxura hd devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.There is no evidence of improper use or storage.

Event Description

Lilly case id: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a 04-year-old (at the time of initial report) male patient of unknown origin.Medical history included historical medication insulin human for unknown indication.Concomitant medications included unspecified vitamin b12 for anemia and calcium deficiency and immuguard (as reported), taken as immune stimulant.The patient received insulin lispro (rdna origin) (humalog) from an unknown formulation via reusable pen device (humapen luxura half dose), with a 3.5 units in the morning, 4.5 units or 5 units in the mid-day (lunch) and 2.5 units or 3.5 units in the night, subcutaneously for the treatment of diabetes mellitus beginning on an unknown date in (b)(6) 2019.On approximately (b)(6) 2019, the injection button of first humapen luxura half dose device was not stuck in its place it seemed like it was dislocated ((b)(4) and lot number unknown).There were three to four drops on the needle after giving the dose they assumed that it was not taking his accurate dose.On approximately (b)(6) 2019, he experienced increased blood glucose and as it reached 400mg/dl although it was 60 mg/dl when he started the therapy (units and range were not provided).Outcome for the events was not recovered.Approximately, on (b)(6) 2019, the injection button of humapen luxura hd (second device) was not stuck on its place and it seemed like it would be dislocated ((b)(4)and lot no 1801g01).His mother always found that there was all insulin on his arms after he had his dose although increasing his doses and counting from one to ten before the pen was removed.Therefore, it was assumed that he was not taking his accurate dose.Although when he started insulin lispro therapy his blood glucose was 60 mg/dl but since (b)(6) 2019, his blood glucose level was high and it reached 600mg/dl.The event of blood glucose increased (second episode) was considered as serious by the company due to medically significant reason.On (b)(6) 2019, he was recovered from blood glucose increased (second episode) and incorrect dose administered (second episode).As of (b)(6) 2019, he was taking his insulin doses by insulin syringe and his blood glucose level was adjusted at morning 80 mg/dl and measured after that was 240 mg/dl.Information regarding the corrective treatment was unknown.Insulin lispro therapy was ongoing.The operator of both humapen luxura half dose was mother of patient and her training status was not provided.The general model duration use for humapen luxura hd was around two months.The first suspect humapen luxura hd duration of use for was six or seven days.The second suspect humapen luxura hd duration of use was around two months.The use of the suspect devices were ongoing.The suspect devices were not returned to the manufacturer.The initial reporting consumer did not relate the event of incorrect dose administered (first episode) with the insulin lispro therapy but related it with humapen luxura hd (first pen).The initial reporting consumer did not know the relatedness between the event of blood glucose increased (first episode) with insulin lispro therapy and with the humapen luxura hd (first pen).The initial reporting consumer did not relate the event of blood glucose increased (second episode) with insulin lispro therapy and related the event of incorrect dose administered (second episode) with insulin lispro therapy.The initial reporting consumer related the events of blood glucose increased (second episode) and incorrect dose administered (second episode) with humapen luxura hd (second pen).Update 21-aug-2019: additional information was received from initial reporting consumer via a psp on 15-aug-2019.This case was upgraded to serious due to addition of two serious events of blood glucose increased (second episode) and blood glucose decreased.Added: one non- serious event of incorrect dose administered (second episode), one suspect reusable device of humapen luxura hd, three laboratory tests of blood glucose, historical medication of insulin human for unknown indication and eu/ca fields of second suspect device.Updated: dosage regimen of humalog.Upon review of information received on 06-jul-2019, updated the first suspect device from humapen luxura unknown body type to humapen luxura hd, corrected the as reported causality of event incorrect dose administered from yes to no (not related) and product complaint was re-processed for first suspect device.Causality statement, device paragraph and narrative was updated with new information accordingly.Edit 27-aug-2019: per affiliate review of information received on 15-aug-2019, updated laboratory test result of 24 mg/dl to 240mg/dl; deleted serious event of blood glucose decreased and updated description of non-serious event of blood glucose increased.Updated narrative accordingly.Edit 30-aug-2019: upon review of information received on 15-aug-2019, updated the model numbers of both humapen luxura hd pens and no other changes were made in the case.Edit 06-sep-2019: upon review of information received on 15-aug-2019, updated general model duration use for humapen luxura hd in device paragraph, narrative was updated with (b)(4) and moved the pc citation behind the complaint description.No other changes were made in the case.Edit 09sep2019: updated medwatch fields for expedited device reporting.No new information added.Edit 09sep2019: updated medwatch fields for expedited device reporting, unique identifier number.No new information added.Update 10sep2019: additional information received on 10sep2019 from the global product complaint database.Entered the device specific safety summary (dsss).Updated the medwatch and european and canadian (eu/ca) device fields.Added the date of return for the suspect device associated with (b)(4).Corresponding fields and narrative updated accordingly.

• 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: 8981814
• MDR Text Key: 161682459
• Report Number: 1819470-2019-00157
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00300029673019
• UDI-Public: 00300029673019
• Combination Product (y/n): N
• PMA/PMN Number: K100988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9673A
• Device Lot Number: 1801G01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 YR