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

Model Number MS9673A

Device Problems Fracture (1260); Component Missing (2306)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Date 06/22/2021

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) female patient of an unknown origin.Medical history and concomitant medications were not provided.The patient received human insulin isophane suspension (rdna origin) injections (humulin), from cartridge via a reusable device humapen luxura hd, for the treatment of diabetes mellitus, beginning in 2010.She was using humapen luxura hd since 2010 which was improper use.Dosage regimen and route of administration were not provided.On (b)(6) 2021, while on human insulin treatment, her ketone levels were elevated due to infection and blood glucose was elevated to 600 (units and reference range were not provided).On an unknown date, she was hospitalized due to the events and hospitalized in intensive care for 2.5 days.At hospital, the metal piece of humapen luxura hd went missing and the injection was made via pressing with a coin to pen and she received the medication with insulin injector (lot number: unknown, product complaint (pc) number: (b)(4)).On an unknown date, she was transferred to another hospital and continued to stay there after exiting from intensive care on (b)(6) 2021.On (b)(6) 2021, her blood glucose was normal at 150-160 and she was going to be discharged.Information regarding corrective treatment and outcome of remaining events was not provided.Status of human insulin treatment was continued.Follow up was not possible as the consent to contact reporter for further follow up was declined.The operator of humapen luxura hd and his/her training status was not provided.The general humapen luxura hd duration was not provided and suspect humapen luxura hd duration was approximately 11 years as it was started in 2010.The humapen luxura hd was ongoing and information regarding its return was not provided.The initial reporting consumer did not provide an opinion of relatedness between the events and human insulin treatment or humapen luxura hd.Edit (b)(6) 2021: updated medwatch and (b)(6) fields for expedited device reporting.No new information added.Update 05-jul-2021: information was received from the responsible complaint personnel (rcp) on (b)(6) 2021.Added pc number and no medical significant information was received and hence no other changes were made to the case.Update 12-jul-2021: upon correction by the local affiliate of the information initially received on (b)(6) 2021, contained information regarding correct gender of the patient.Updated gender of the patient from male to female and narrative with new information.Edit (b)(6) 2021: added udi number for expedited device reporting and added contact log accordingly.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 17-year-old female patient of an unknown origin.Medical history and concomitant medications were not provided.The patient received human insulin isophane suspension (rdna origin) injections (humulin), from cartridge via a reusable device humapen luxura hd, for the treatment of diabetes mellitus, beginning in 2010.She was using humapen luxura hd since 2010 which was improper use.Dosage regimen and route of administration were not provided.On (b)(6)2021, while on human insulin treatment, her ketone levels were elevated due to infection and blood glucose was elevated to 600 (units and reference range were not provided).On an unknown date, she was hospitalized due to the events and hospitalized in intensive care for 2.5 days.At hospital, the metal piece of humapen luxura hd went missing and the injection was made via pressing with a coin to pen and she received the medication with insulin injector (lot number: unknown, product complaint (pc) number:(b)(4).On an unknown date, she was transferred to another hospital and continued to stay there after exiting from intensive care on (b)(6( 2021.On (b)(6) 2021, her blood glucose was normal at 150-160 and she was going to be discharged.Information regarding corrective treatment and outcome of remaining events was not provided.Status of human insulin treatment was continued.Follow up was not possible as the consent to contact reporter for further follow up was declined.The operator of humapen luxura hd and his/her training status was not provided.The general humapen luxura hd duration was not provided and suspect humapen luxura hd duration was approximately 11 years as it was started in 2010.The humapen luxura hd was ongoing and was not returned to manufacturer.The initial reporting consumer did not provide an opinion of relatedness between the events and human insulin treatment or humapen luxura hd.Edit 01jul2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 05-jul-2021: information was received from the responsible complaint personnel (rcp) on 30-jun-2021.Added pc number and no medical significant information was received and hence no other changes were made to the case.Update 12-jul-2021: upon correction by the local affiliate of the information initially received on 29-jun-2021, contained information regarding correct gender of the patient.Updated gender of the patient from male to female and narrative with new information.Edit 14jul2021: added udi number for expedited device reporting and added contact log accordingly.No new information added.Update 15jul2021: additional information received on 15jul2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information and device return status to not returned to manufacturer for (b)(4) associated with unknown lot of humapen luxura hd 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(s) dated 15jul2021 in the b.5.Field.No further follow-up is planned.Evaluation summary a consumer reported on behalf of a female patient that the "metal piece of the humapen luxura hd went missing and the injection was made via pressing with a coin to pen." the patient experienced increased blood glucose.The device was not returned for investigation (batch unknown).Therefore, the device 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 patient reportedly used the device for approximately eleven years.The core instructions for use state the humapen luxura hd is designed to be used for up to three years after first use.The core instructions for use also states to always carry a spare insulin pen in case your pen is lost or damaged.There is evidence of improper use.The patient used the device beyond its approved use life.It is unknown if this misuse is relevant to the complaint for the event of increased blood glucose.

• 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
• MDR Report Key: 12167315
• MDR Text Key: 264515368
• Report Number: 1819470-2021-00090
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00300029673019
• UDI-Public: 00300029673019
• Combination Product (y/n): N
• PMA/PMN Number: K100988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/14/2021
• Supplement Dates Manufacturer Received: 07/15/2021
• Supplement Dates FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 17 YR