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

Model Number MS9673A

Device Problems Mechanical Jam (2983); Insufficient Information (3190)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 10/31/2023

Event Type  Injury  

Event Description

Lilly case id: (b)(6).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer, via a patient support program, concerned a 19-years old male patient of unknown origin.Medical history was not reported.The concomitant medications included tresiba administered for type 1 diabetes mellitus.The patient received insulin lispro (rdna origin) injections, from a cartridge, subcutaneously, dose depending upon carbohydrates he consumed, it could be up to 40 units and after a range of 281-380 mg/dl of glucose, the doctor prescribed him to increase 5 more units (frequency unknown), for the treatment of type 1 diabetes mellitus, applied in the stomach and legs, via a reusable pen humapen luxura half dose pen.He also received insulin lispro (rdna origin) injections (humalog u100u/ml) via a pre-filled pen kwikpen, subcutaneously, for type 1 diabetes, dose depending upon carbohydrates he consumed.Therapy start date and frequency of administration were unknown.It was reported he started insulin lispro therapy since an unknown date in (b)(6) 2018 (specific therapy start dates of insulin lispro cartridge and insulin lispro kwikpen were unknown).On unspecified date humapen luxura hd device stopped working during turning the dose button and was replaced on an unknown date in 2019.On unspecified date, the humapen luxura hd with lot 1703g01 was not working properly further described as sticking not rotating, and when she inserted the cartridge, she was unable to turn the knob.At the moment of injecting, it got stuck ((b)(4) /lot 1703g01).It was reported his blood glucose was not stable, and the doctors tried to lower his blood glucose and keep it stable, but he had diabetes, and his blood glucose was variable.In approximately (b)(6) 2023, the patient acquired insulin lispro cartridges, one cartridge was broken but the other cartridge was fine and was used (unknown when used).On unknown date in (b)(4) 2023, while using insulin lispro cartridge via humapen luxura hd device, he lost consciousness, he fainted because he presented a very strong hypoglycemia referring below 30 mg/dl of glucose (reference range unknown).He fell from the fainting and had some small bumps on his head due to the fall.Due to a higher dose application; the carbohydrates were not well counted, and insulin lispro dose was misapplied (the reporter did not remember the application dose at that time).It was reported he was in class and could not eat something when he fell sick.As corrective treatment, he was given sweets to raise his glucose levels and he was treated and was fine, he recovered the same day.On (b)(6) 2023, he underwent a knee operation and mentioned he could not climb the stairs fast.It was reported he was hospitalized overnight and on (b)(6) 2023 he was discharged.When he had knee surgery, he had an elevation of glucose (the glucose range was unknown) however, it reached more than 280 mg/dl due to the medications he was given.He presented these glucose levels when he had an elevation of carbohydrates, when he got up at dawn or when he got sick with flu or stomach symptoms.It was reported these symptoms elevated glucose due to some infection.As a corrective treatment he was applied the corresponding dose of insulin.While administering insulin, he reused the needle of his devices up to three times and used device with lot number 1703g01 four years (considered improper use).No further information was provided at the time of the report.The events hypoglycemic unconsciousness and fall were considered serious by the company due to medical significance.Further information regarding corrective treatment was unknown.Outcome of hypoglycemic unconsciousness was recovered, and outcome of remaining events were unknown.Status of insulin lispro was unknown.The operator of humapen savvio green and kwikpen was unknown, and his/her training status was not provided.The general humapen was started since an unknown date in 2018 and suspect humapen model duration of use was approximately four years.The general and suspect kwikpen model duration of use was unknown.The action taken with suspect humapen unknown, and its return status was unknown.The action taken with kwikpen was unknown and its return was not expected.The reporting consumer did not consider the events related with insulin lispro therapy and did not provide relatedness of events with humapen or kwikpen devices.Edit 18-jan-2024: upon internal review on information received on 20-dec-2023, updated coding from savvio devices to humapen luxura hd devices, clarified improper use, updated relatedness, and updated narrative.Corresponding fields and narrative updated accordingly.Edit 18jan2024: 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.A follow-up report will be submitted when the final evaluation is completed.

Manufacturer Narrative

B.5.Narrative field: new, updated, and corrected information is referencedwithin the update statements in b.5.Please refer to update statement(s) dated 07feb2024 in the b.5.Field.No further follow-up is planned.Evaluation summary: the mother of a male patient reported that her son's humapen luxura hd device "was not working properly further described as sticking not rotating, and when she inserted the cartridge, she was unable to turn the knob.At the moment of injecting, it got stuck." the patient experienced hypoglycemic unconsciousness.The investigation of the returned device (batch 1703g01, manufactured march 2017) found the device met functional requirements.No malfunction was identified.The investigation also observed that the case was damaged, and the cartridge holder printing was worn and faded from exposure to an unknown chemical while in the field.These non-reported findings did not impact the function of the device.The core instructions for use states "do not cover in liquid or apply lubrication such as oil, as this could damage the pen." the device was difficult to manually back drive; however, this did not impact the dosing function of the device.The patient used luxura hd for four years.The core instructions for use state the humapen luxura hd has been designed to be used for up to 3 years after first use.The patient used the same needle up to three times.The core instructions for use state to use a new needle for each injection.There is evidence of improper use.The patient used the device beyond the recommended use period and applied a foreign material to the device.These misuses are not likely relevant to the complaint since the device functioned normally.The patient reused needles.This misuse may be relevant to the complaint issue.It is unknown if these misuses are relevant to the event of hypoglycemic unconsciousness.

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, concerned a 19-years old male patient of unknown origin.Medical history was not reported.The concomitant medications included tresiba administered for type 1 diabetes mellitus.The patient received insulin lispro (rdna origin) injections, from a cartridge, subcutaneously, dose depending upon carbohydrates he consumed, it could be up to 40 units and after a range of 281-380 mg/dl of glucose, the doctor prescribed him to increase 5 more units (frequency unknown), for the treatment of type 1 diabetes mellitus, applied in the stomach and legs, via a reusable pen humapen luxura half dose pen.He also received insulin lispro (rdna origin) injections (humalog u100u/ml) via a pre-filled pen kwikpen, subcutaneously, for type 1 diabetes, dose depending upon carbohydrates he consumed.Therapy start date and frequency of administration were unknown.It was reported he started insulin lispro therapy since an unknown date in (b)(6) 2018 (specific therapy start dates of insulin lispro cartridge and insulin lispro kwikpen were unknown).On unspecified date humapen luxura hd device stopped working during turning the dose button and was replaced on an unknown date in 2019.On unspecified date, the humapen luxura hd with lot 1703g01 was not working properly further described as sticking not rotating, and when she inserted the cartridge, she was unable to turn the knob.At the moment of injecting, it got stuck ((b)(4) /lot 1703g01).It was reported his blood glucose was not stable, and the doctors tried to lower his blood glucose and keep it stable, but he had diabetes, and his blood glucose was variable.In approximately (b)(6) 2023 the patient acquired insulin lispro cartridges, one cartridge was broken but the other cartridge was fine and was used (unknown when used).On unknown date in (b)(6) 2023 while using insulin lispro cartridge via humapen luxura hd device, he lost consciousness, he fainted because he presented a very strong hypoglycemia referring below 30 mg/dl of glucose (reference range unknown).He fell from the fainting and had some small bumps on his head due to the fall.Due to a higher dose application; the carbohydrates were not well counted, and insulin lispro dose was misapplied (the reporter did not remember the application dose at that time).It was reported he was in class and could not eat something when he fell sick.As corrective treatment, he was given sweets to raise his glucose levels and he was treated and was fine, he recovered the same day.On (b)(6) 2023 he underwent a knee operation and mentioned he could not climb the stairs fast.It was reported he was hospitalized overnight and on (b)(6) 2023 he was discharged.When he had knee surgery, he had an elevation of glucose (the glucose range was unknown) however, it reached more than 280 mg/dl due to the medications he was given.He presented these glucose levels when he had an elevation of carbohydrates, when he got up at dawn or when he got sick with flu or stomach symptoms.It was reported these symptoms elevated glucose due to some infection.As a corrective treatment he was applied the corresponding dose of insulin.While administering insulin, he reused the needle of his devices up to three times and used device with lot number 1703g01 four years (considered improper use).No further information was provided at the time of the report.The events hypoglycemic unconsciousness and fall were considered serious by the company due to medical significance.Further information regarding corrective treatment was unknown.Outcome of hypoglycemic unconsciousness was recovered, and outcome of remaining events were unknown.Status of insulin lispro was unknown.The operator of humapen luxura hd and kwikpen was unknown, and his/her training status was not provided.The general humapen was started since an unknown date in 2018 and suspect humapen model duration of use was approximately four years.The general and suspect kwikpen model duration of use was unknown.The action taken with suspect humapen unknown, and device was returned to the manufacturer.The action taken with kwikpen was unknown and its return was not expected.The reporting consumer did not consider the events related with insulin lispro therapy and did not provide relatedness of events with humapen or kwikpen devices.Edit 18-jan-2024: upon internal review on information received on 20-dec-2023, updated coding from savvio devices to humapen luxura hd devices, clarified improper use, updated relatedness, and updated narrative.Corresponding fields and narrative updated accordingly.Edit 18jan2024: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 07feb2024: additional information received on 06aug2024 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 for the suspect device humapen luxura hd 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
• Manufacturer (Section G): PHILLIPS-MEDISIZE CORPORATION; medical device manufacturing; 415 red cedar street; menomonie WI 54751
• Manufacturer Contact: catherine cassidy ; lilly corporate center; indianapolis, IN 46285 ; 3174332191
• MDR Report Key: 18535679
• MDR Text Key: 333149294
• Report Number: 1819470-2023-00086
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00300029673019
• UDI-Public: 00300029673019
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K100988
• 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
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9673A
• Device Lot Number: 1703G01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2017
• 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): Other
• Patient Age: 19 YR
• Patient Sex: Male
• Patient Weight: 95 KG