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 Problem Hyperglycemia (1905)

Event Date 01/31/2018

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 solicited case, reported by a consumer via a patient support program (psp), concerned a 03-year-old (at the time of initial report) male patient of unknown origin.Medical history and concomitant medication were not provided.The patient received insulin lispro (rdna origin) injection (humalog 100u/ml) from cartridge via humapen luxura hd, at unknown dose, three times a day, subcutaneously, for the treatment of diabetes mellitus, beginning on an unspecified date in (b)(6)2018.On an unknown date in 2018, while on insulin lispro therapy, his blood glucose level was 1017 (units and reference range was not provided) due to which he went to the hospital.His blood glucose level remained high constantly because of the patient eating sugar things.On (b)(6)2023, there was hardening in the humapen luxura hd, and he had difficulty with humapen luxura hd.The application pen was about to deteriorate, the application pen head had hardened, and it was hard to press (pc number: (b)(4), lot number: unknown).He had been using ayset as a needle tip brand.On an unknown date, he was eating sugar things and therefore his blood glucose level increased to 500-600 (unit was not provided).On (b)(6)2023, the application pen was working.Information regarding the corrective treatment details, further hospitalization details, outcome of events and status of insulin lispro therapy were not provided.Follow-up was not possible as reporter refused to provide more information and treating physician contact details were not provided.The operator of the device was patient father and his training status was not provided.The device model, duration of use was not provided but was started on an unspecified date and suspect device duration of use was not reported.The suspect device was working fine and its return status was not expected.The initial reporting consumer did not provide the relatedness assessment of the events with the insulin lispro therapy and humapen luxura hd device.Edit 10-mar-2023: upon review of information received on 03-mar-2023, added product complaint (pc) information in narrative.Added two non-serious event of blood glucose increased.Updated priority of case to priority 2, outcome of first episode to blood glucose increased from not recovered to unknown and narrative with new information.Edit 11-mar-2023: upon review of information received on 03-mar-2023, removed extra listedness for the non-serious event of blood glucose level increased to 500-600, other than core listedness.No other changes were made to the case.Update 16-mar-2023: information was received on 08-mar-2023 contained product complaint (pc) number.No new information was added to the case.Edit 28mar2023: updated medwatch 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 solicited case, reported by a consumer via a patient support program (psp), concerned a 03-year-old (at the time of initial report) male patient of unknown origin.Medical history and concomitant medication were not provided.The patient received insulin lispro (rdna origin) injection (humalog 100u/ml) from cartridge via humapen luxura hd, at unknown dose, three times a day, subcutaneously, for the treatment of diabetes mellitus, beginning on an unspecified date in apr-2018.On an unknown date in 2018, while on insulin lispro therapy, his blood glucose level was 1017 (units and reference range was not provided) due to which he went to the hospital.His blood glucose level remained high constantly because of the patient eating sugar things.On (b)(6) 2023, there was hardening in the humapen luxura hd, and he had difficulty with humapen luxura hd.The application pen was about to deteriorate, the application pen head had hardened, and it was hard to press (pc number: (b)(4), lot number: unknown).He had been using ayset as a needle tip brand.On an unknown date, he was eating sugar things and therefore his blood glucose level increased to 500-600 (unit was not provided).On 03-mar-2023, the application pen was working.Information regarding the corrective treatment details, further hospitalization details, outcome of events and status of insulin lispro therapy were not provided.Follow-up was not possible as reporter refused to provide more information and treating physician contact details were not provided.The operator of the device was patient father and his training status was not provided.The device model, duration of use was not provided but was started on an unspecified date and suspect device duration of use was not reported.The suspect device was working fine and was not returned to returned to the manufacturer for investigation.The initial reporting consumer did not provide the relatedness assessment of the events with the insulin lispro therapy and humapen luxura hd device.Edit 10-mar-2023: upon review of information received on 03-mar-2023, added product complaint (pc) information in narrative.Added two non-serious event of blood glucose increased.Updated priority of case to priority 2, outcome of first episode to blood glucose increased from not recovered to unknown and narrative with new information.Edit 11-mar-2023: upon review of information received on 03-mar-2023, removed extra listedness for the non-serious event of blood glucose level increased to 500-600, other than core listedness.No other changes were made to the case.Update 16-mar-2023: information was received on 08-mar-2023 contained product complaint (pc) number.No new information was added to the case.Edit 28mar2023: updated medwatch fields for expedited device reporting.No new information added.Update 06apr2023: additional information received on 29mar2023 from the global product complaint database.Recoded the suspect device humapen luxura hd from model number (item code) ms9673 to ms9673a associated with product complaint number (b)(4).Entered device specific safety summary (dsss) for humapen luxura hd associated with pc (b)(4), lot unknown.Updated the medwatch fields/ european and canadian (eu/ca) device information and device return status to not returned to manufacturer, improper use was updated as yes, unique identifier (udi) number was updated.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 06apr2023 in the b.5.Field.No further follow-up is planned.Evaluation summary: the father of a male patient reported that on (b)(6) 2023 "there was hardening in the humapen luxura hd, and he had difficulty with humapen luxura hd.The application pen was about to deteriorate, the application pen head had hardened, and it was hard to press." the patient experienced increased blood glucose.He reported that on 03-mar-2023, the application pen was working.The device was not returned to the manufacturer for investigation (batch number unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen luxura hd devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.The user reported the device had been used since april 2018.The core instructions for use states the humapen luxura hd has been designed to be used for up to 3 years after first use.There is evidence of improper use.The patient used the device beyond the recommended use period.It is unlikely this misuse is relevant to the complaint or the event of increased blood glucose since the device was subsequently reported to be working.

• Brand Name: HUMAPEN LUXURA HALF-DOSE PEN
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis
• Manufacturer (Section G): PHILLIPS-MEDISIZE CORPORATION; medical device manufacturing; 415 red cedar street; menomonie WI
• Manufacturer Contact: chris davis ; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 16659595
• MDR Text Key: 312497542
• Report Number: 1819470-2023-00022
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00300029673019
• UDI-Public: 00300029673019
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9673A
• Device Catalogue Number: MS9673
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 3 YR
• Patient Sex: Male