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

Model Number MS9673A

Device Problems Fitting Problem (2183); Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 02/08/2023

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 2-year-old infant male patient of an unknown origin.Medical history included type-i diabetes mellitus.Concomitant medications were not reported.The patient received insulin lispro (rdna origin) injections (humalog 100 u/ml) from cartridge via a reusable device (humapen luxura half-dose device), subcutaneously for the treatment of type-i diabetes mellitus beginning on an unknown date approximately in (b)(6) 2021.Dose and frequency were not provided.From on an unknown date, approximately since (b)(6) 2021, he started to use the humapen luxura hd device.On an unknown date, starting the insulin lispro therapy, the needle attached to humapen luxura hd device was sliding and did not fit the application pen constantly.The needle tip part of the application pen was deformed, and the pen was defective ((b)(4); lot-1811g02).Approximately since 08-feb-2023, his blood glucose level was imbalance and was increasing and decreasing.As of 15-feb-2023, the blood glucose level was 35 (unit and reference range were not provided).The event of blood glucose fluctuation was considered as serious by the company due to its medical significance.Information regarding corrective treatment, outcome of the event and status of insulin lispro therapy was not provided.Follow-up was not possible with reporter and physician as the reporter did not give consent for follow-up procedures.The operator of the reusable device and his/her training status was unknown.General device model duration of use was not provided, and suspect device duration of use was 18 months.The action taken with the humapen luxura hd device was not provided and its return status was not expected.The reporting consumer did not provide the relatedness of the event with insulin lispro and considered that the event was related to humapen luxura hd device.Edit 22feb2023: updated medwatch 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 24mar2023 in the b.5.Field.No further follow-up is planned.Evaluation summary: the father of a male patient reported that the needle attached to the patient's humapen luxura hd device was sliding and did not fit the application pen, and it scrolled constantly.He alleged "the needle tip part of the application pen was deformed." the patient experienced blood glucose fluctuation.The device was not returned to the manufacturer for investigation (batch 1811g02, manufactured november 2018).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review did not identify any atypical findings regarding needle attachment, cartridge holder thread end, or dose accuracy issues.The complaint device was in use for 18 months, indicating that the needle application thread ends of cartridge holder functioned until the reported needle attachment issue; therefore, no manufacturing issue is indicated.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 2-year-old infant male patient of an unknown origin.Medical history included type-i diabetes mellitus.Concomitant medications were not reported.The patient received insulin lispro (rdna origin) injections (humalog 100 u/ml) from cartridge via a reusable device (humapen luxura half-dose device), subcutaneously for the treatment of type-i diabetes mellitus beginning on an unknown date approximately in (b)(6) 2021.Dose and frequency were not provided.From on an unknown date, approximately since (b)(6) 2021, he started to use the humapen luxura hd device.On an unknown date, starting the insulin lispro therapy, the needle attached to humapen luxura hd device was sliding and did not fit the application pen constantly.The needle tip part of the application pen was deformed, and the pen was defective (b)(4); lot-1811g02).Approximately since (b)(6) 2023, his blood glucose level was imbalance and was increasing and decreasing.As of (b)(6) 2023, the blood glucose level was 35 (unit and reference range were not provided).The event of blood glucose fluctuation was considered as serious by the company due to its medical significance.Information regarding corrective treatment, outcome of the event and status of insulin lispro therapy was not provided.Follow-up was not possible with reporter and physician as the reporter did not give consent for follow-up procedures.The operator of the reusable device and his/her training status was unknown.General device model duration of use was not provided, and suspect device duration of use was 18 months.The action taken with the humapen luxura hd device was not provided and device was not returned.The reporting consumer did not provide the relatedness of the event with insulin lispro and considered that the event was related to humapen luxura hd device.Edit 22feb2023: updated medwatch fields for expedited device reporting.No new information added.Update 24mar2023: additional information received on 23mar2023 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information and date of manufacturer.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: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 16420853
• MDR Text Key: 310008327
• Report Number: 1819470-2023-00015
• 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: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• 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
• Device Lot Number: 1811G02
• Was Device Available for Evaluation?: No
• 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): Other
• Patient Age: 2 YR
• Patient Sex: Male