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

Model Number MS9673A

Device Problems Failure to Deliver (2338); Mechanical Jam (2983); Activation Failure (3270)

Patient Problem Hyperglycemia (1905)

Event Date 11/06/2021

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 (b)(6) year-old, female patient of an unknown origin.Medical history was not provided.Concomitant medication included insulin glargine used for the treatment of diabetes mellitus beginning on an unknown date.The patient received insulin lispro (rdna origin) injections (humalog 100 u/ml) cartridge via reusable pen (humapen luxura half-dose) device, subcutaneously three times in a day, for the treatment of diabetes mellitus beginning on an unknown date in (b)(6) 2021.She would add another dose of insulin lispro treatment if her blood sugar increased.Approximately, on (b)(6) 2021, the humapen luxura hd device issue.Humapen luxura hd device did not inject insulin lispro when the button was pressed.The head of the application pen did not go down when it was pressed.She possibly did not received the dose of insulin lispro due to humapen luxura hd device issue ((b)(4); lot# 1808g01).On (b)(6) 2021, her blood sugar level was high.On an unknown date, she was hospitalized due to blood glucose increased.Outcome of the events was not provided.Insulin lispro treatment was continued.Follow up not possible as the reporter did not give consent for follow-up procedures.The patients mother was operator of humapen luxura hd device and her training status was not provided.The model device duration of use for humapen luxura hd was unknown.Suspect humapen luxura hd device age was approximately nine months.The use of the suspect humapen luxura hd reusable device was discontinued and it was returned to the manufacturer on 23-nov-2021.The reporting consumer did not provide the relatedness of the events with insulin lispro drug.The reporting consumer did not provide the relatedness of the event of blood sugar increased with humapen luxura hd device whereas related the missed dose with it.Update 25-nov-2021: additional information was received from global product complaint department on 23-nov-2021.Added humapen luxura hd lot number, device age and updated its coding to correct model and status of availability as return to manufacturer.Updated case and narrative with new information.Update 25nov2021:additional information received on 23nov2021 from global product complaint database.Reiterated the lot number 1808g01 for product complaint (b)(4) related to humapen luxura half-dose device which was already present and correct in the case.Corresponding fields and narrative updated accordingly.Edit 01dec2021: updated medwatch and european and (b)(6) 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 04-year-old, female patient of an unknown origin.Medical history was not provided.Concomitant medication included insulin glargine used for the treatment of diabetes mellitus beginning on an unknown date.The patient received insulin lispro (rdna origin) injections (humalog 100 u/ml) cartridge via reusable pen (humapen luxura half-dose) device, subcutaneously three times in a day, for the treatment of diabetes mellitus beginning on an unknown date in (b)(6) 2021.She would add another dose of insulin lispro treatment if her blood sugar increased.Approximately, on (b)(6) 2021, the humapen luxura hd device issue.Humapen luxura hd device did not inject insulin lispro when the button was pressed.The head of the application pen did not go down when it was pressed.She possibly did not received the dose of insulin lispro due to humapen luxura hd device issue ((b)(4) ; lot 1808g01).On (b)(6) 2021, her blood sugar level was high.On an unknown date, she was hospitalized due to blood glucose increased.Outcome of the events was not provided.Insulin lispro treatment was continued.Follow up not possible as the reporter did not give consent for follow-up procedures.The patients mother was operator of humapen luxura hd device and her training status was not provided.The model device duration of use for humapen luxura hd was unknown.Suspect humapen luxura hd device age was approximately nine months.The use of the suspect humapen luxura hd reusable device was discontinued and it was returned to the manufacturer on 23-nov-2021.The reporting consumer did not provide the relatedness of the events with insulin lispro drug.The reporting consumer did not provide the relatedness of the event of blood sugar increased with humapen luxura hd device whereas related the missed dose with it.Update 25-nov-2021: additional information was received from global product complaint department on 23-nov-2021.Added humapen luxura hd lot number, device age and updated its coding to correct model and status of availability as return to manufacturer.Updated case and narrative with new information.Update 25nov2021:additional information received on 23nov2021 from global product complaint database.Reiterated the lot number 1808g01 for product complaint (b)(4) related to humapen luxura half-dose device which was already present and correct in the case.Corresponding fields and narrative updated accordingly.Edit 01dec2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 06jan2022: additional information received on 05jan2022 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information for (b)(4) associated with lot number 1808g01 of humapen luxura hd device.Updated date of manufacturer and malfunction 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 (s) dated 07jan2022 in the b.5.Field.No further follow-up is planned.This is a downgrade report that no longer meets the criteria for expedited reporting.Evaluation summary: the mother of a female patient reported that the patient's humapen luxura hd device did not inject insulin when the injection button was pressed, and the "head of the application pen did not go down when it was pressed." the patient experienced increased blood glucose.Investigation of the returned device (batch 1808g01, manufactured august 2018) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.There is no evidence of improper use or storage.

• 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: 12918777
• MDR Text Key: 286445998
• Report Number: 1819470-2021-00162
• 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: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• 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: 1808G01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/23/2021
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2018
• 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: 4 YR
• Patient Sex: Female