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

Model Number MS9673A

Device Problems Insufficient Flow or Under Infusion (2182); Mechanical Jam (2983); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Diabetic Ketoacidosis (2364)

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, concerns a (b)(6) year-old male patient of unknown ethnicity.The medical history of patient and concomitant medication was not provided.The patient received insulin lispro (humalog) from cartridges via humapen luxura device (unknown model), at unknown dose, frequency, route of administration for the treatment of type one diabetes mellitus, beginning on unknown date.On unknown date, unknown time after beginning insulin lispro, the pen was bad to apply, it was heavy (as reported) (batch number unknown; product complaint number (b)(4)), and patient was hospitalized after a ketoacidosis crisis because they were not being able to apply the insulin.No further information was provided.Information regarding corrective treatments, laboratory exams and event outcome was not provided.It was unknown if any actions were taken regarding insulin lispro therapy.The operator of the device and the training status was unknown.The duration of use for this device model and for this reported suspect device was unknown.Status and return status of device were not provided.The reporting consumer related the ketoacidosis crisis with not being able to apply the medication and did not provide any other opinion of relatedness.Edit 12apr2022: upon internal review, it was determined by source document received on 04apr2022, that the reporter did not specify which humapen luxura model was used, so, the device name was updated to humapen luxura unknown ped body type.Also, updated description as reported for the event of drug dose omission adding degree of harm.Narrative and corresponding fields were updated accordingly.Edit 14apr2022: updated medwatch and (b)(6) 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, concerns a 10-year-old male patient of unknown ethnicity.The medical history of patient and concomitant medication were not provided.The patient received insulin lispro (humalog) cartridges, via humapen luxura half-dose (hd) pen, at unknown dose, frequency, route of administration, for the treatment of type one diabetes mellitus, beginning on unknown date.On unknown date around aug2021, unknown time after beginning insulin lispro treatment, the pen was bad to apply, it was heavy, further described as the pen s string (injector button) was not returning (batch number 1402g05; product complaint number (b)(4)).Due to the pen issue, patient was not able to apply the insulin since an unknown date (described as applying less than expected) and he was hospitalized, from (b)(6) 2022 to or (b)(6) 2022, due to a ketoacidosis crisis.It was also reported that the pen was stored in room temperature, the sealed insulin cartridge was stored in the fridge and the open one was kept attached to the device in room temperature, the needles were changed every application, the needle was kept attached to the device until next application, the application was made on the patient s forearm, lateral of leg and stomach area, but the device priming was not performed every application.No further information was provided.Information regarding corrective treatments, laboratory exams and events outcome was not provided.It was unknown if any actions were taken regarding insulin lispro therapy.The operator of the device was the patient, sometimes with the help from his mother and the training status of both was unknown.The duration of use for this device model was unknown, and the suspect device was being used for approximately four years.Status of device was unknown and was not returned to the manufacturer for investigation.The reporting consumer related the ketoacidosis crisis with not being able to apply the expected dose of insulin (underdose) and considered that the underdose was due to the device issue.No other relatedness opinion was provided.Edit (b)(6) 2022: upon internal review, it was determined by source document received on (b)(6) 2022, that the reporter did not specify which humapen luxura model was used, so, the device name was updated to humapen luxura unknown ped body type.Also, updated description as reported for the event of drug dose omission adding degree of harm.Narrative and corresponding fields were updated accordingly.Edit 14apr2022: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 28apr2022: additional information received on (b)(6) 2022 from the initial reporter.Updated: device unknown model type to humapen luxura half-dose; complaint description; event of missed dose to underdose; and relatedness statement in the narrative.Added: device batch number; hospitalization period; details about device and drug storage and improper use; operator of device; and age of suspect device.Narrative and corresponding fields were updated accordingly.Update 03may2022: additional information received on (b)(6) 2022 from global product complaint database reiterated the lot number 1402g05, model number ms9673a for product complaint (b)(4) relating to humapen luxura half-dose device, which was already present and correct in the case.Corresponding fields and narrative updated accordingly.Update 06may2022: additional information received on 04may2022 from the global product complaint database.Entered device specific safety summary (dsss) for humapen luxura half-dose device associated with pc (b)(4), lot 1402g05.Updated the medwatch fields/ european and canadian (eu/ca) device information and device return status to not returned to manufacturer.Added date of manufacturer for the device.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 dated 06may2022 in the b.5.Field.No further follow-up is planned evaluation summary the mother of a male patient reported that the spring (injection button) was not returning on the humapen luxura hd device since august 2021.Due this issue, patient was not able to apply the insulin since an unknown date (described as applying less than expected).The patient experienced diabetic ketoacidosis and was hospitalized on (b)(6) 2022.The device was not returned to the manufacturer for investigation (batch 1402g05, manufactured february 2014).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.The total number of complaints and the total dose accuracy complaints received for batch 1402g05 is within the established batch threshold and the batch is not atypical.All 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.The patient continued to use the device after experiencing the complaint issue.The core instructions for use states if any of the parts of your humapen luxura hd appear broken or damaged, do not use and to always carry a spare insulin pen in case your pen is lost or damaged.The patient's mother reported the device was in use for approximately four years.The patient stored the device with the needle attached, did not prime the device prior to each injection and continued to use the device after experiencing the complaint issue.The core instructions for use states the humapen luxura hd is designed to be used for up to three years after first use, to not store the pen with a needle attached and to prime the device using 2 units before every injection until insulin is seen at the needle tip.There is evidence of improper use and storage.It is unknown if this misuse is relevant to the complaint or the event of diabetic ketoacidosis.These misuses may be relevant to the event diabetic ketoacidosis.

Event Description

Lilly case id: (b)(4) this report is associated with product complaint: 5935445 this spontaneous case, reported by a consumer, concerns a 10-year-old male patient of unknown ethnicity.The medical history of patient and concomitant medication were not provided.The patient received insulin lispro (humalog) cartridges, via humapen luxura half-dose (hd) pen, at unknown dose, frequency, route of administration, for the treatment of type one diabetes mellitus, beginning on unknown date.On unknown date around aug2021, unknown time after beginning insulin lispro treatment, the pen was bad to apply, it was heavy, further described as the pen s string (injector button) was not returning (batch number 1402g05; product complaint number 5935445).Due to the pen issue, patient was not able to apply the insulin since an unknown date (described as applying less than expected) and he was hospitalized, from (b)(6) 2022 to (b)(6) 2022, due to a ketoacidosis crisis.It was also reported that the pen was stored in room temperature, the sealed insulin cartridge was stored in the fridge and the open one was kept attached to the device in room temperature, the needles were changed every application, the needle was kept attached to the device until next application, the application was made on the patient s forearm, lateral of leg and stomach area, but the device priming was not performed every application.No further information was provided.Information regarding corrective treatments, laboratory exams and events outcome was not provided.It was unknown if any actions were taken regarding insulin lispro therapy.The operator of the device was the patient, sometimes with the help from his mother and the training status of both was unknown.The duration of use for this device model was unknown, and the suspect device was being used for approximately four years.The device was returned to the manufacturer for investigation.The reporting consumer related the ketoacidosis crisis with not being able to apply the expected dose of insulin (underdose) and considered that the underdose was due to the device issue.No other relatedness opinion was provided.Edit 12apr2022: upon internal review, it was determined by source document received on 04apr2022, that the reporter did not specify which humapen luxura model was used, so, the device name was updated to humapen luxura unknown ped body type.Also, updated description as reported for the event of drug dose omission adding degree of harm.Narrative and corresponding fields were updated accordingly.Edit 14apr2022: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 28apr2022: additional information received on 26apr2022 from the initial reporter.Updated: device unknown model type to humapen luxura half-dose; complaint description; event of missed dose to underdose; and relatedness statement in the narrative.Added: device batch number; hospitalization period; details about device and drug storage and improper use; operator of device; and age of suspect device.Narrative and corresponding fields were updated accordingly.Update 03may2022: additional information received on 27apr2022 from global product complaint database reiterated the lot number 1402g05, model number ms9673a for product complaint 5935445 relating to humapen luxura half-dose device, which was already present and correct in the case.Corresponding fields and narrative updated accordingly.Update 06may2022: additional information received on 04may2022 from the global product complaint database.Entered device specific safety summary (dsss) for humapen luxura half-dose device associated with pc 5935445, lot 1402g05.Updated the medwatch fields/ european and canadian (eu/ca) device information and device return status to not returned to manufacturer.Added date of manufacturer for the device.Corresponding fields and narrative updated accordingly.Edit (b)(6) 2022: the case was unlocked to capture unique device identifier (udi) field for humapen luxura half-dose device.Update 29jul202 additional information received on 25jul2022 from the global product complaint database.Updated device specific safety summary (dsss) for humapen luxura half-dose device associated with pc 5935445, lot 1402g05.Updated the medwatch fields/ european and canadian (eu/ca) device information and device return status to returned to manufacturer.Added date of device returned to manufacturer and device malfunction was updated from unknown to no.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 dated 29jul2022 in the b.5.Field.No further follow-up is planned.Evaluation summary the mother of a male patient reported that the spring (injection button) not coming back on humapenluxura hd since (b)(6) 2021.Due to issue, patient was not able to apply the insulin since an unknown date (described as applying less than expected).The patient experienced diabetic ketoacidosis and was hospitalized on (b(6) 2022.Investigation of the returned device (batch 1402g05, manufactured feb2014) found that initially the device dosed with difficulty and the injection force was uneven; however, testing by the manufacturer found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.The investigation also found that the cartridge holder printing was worn and faded which is due to exposure to an unknown chemical, and the lens was broken off.The core instructions for states,do not use alcohol, hydrogen peroxide, bleach, cover in liquid or apply lubrication such as oil, as this could damage the pen.The patient continued to use the device after experiencing the complaint issue.The core instructions for use states if any of the parts of your humapenluxura hd appear broken or damaged, do not use and to always carry a spare insulin pen in case your pen is lost or damaged, humapen luxura hd is designed to be used for up to three years after first use, not to store the pen with a needle attached, to prime the device using 2 units before every injection until insulin is seen at the needle tip.There is evidence of improper use and storage.The patient used the device beyond its approved use life for approximately four years, stored the device with the needle attached, did not prime the device prior to each injection and continued to use the device after experiencing the complaint issue.These misuses are not likely relevant to the event of diabetic ketoacidosis since the device met functional requirements and met dose accuracy and glide (injection) force specifications.

• 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: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 14161338
• MDR Text Key: 289695418
• Report Number: 1819470-2022-00029
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00300029673019
• UDI-Public: 00300029673019
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K100988
• 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,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9673A
• Device Catalogue Number: MS9673
• Device Lot Number: 1402G05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2014
• 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: 10 YR
• Patient Sex: Male