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

Model Number MS9673A

Device Problems Improper or Incorrect Procedure or Method (2017); No Flow (2991); Unintended Movement (3026); Device Fell (4014); Incomplete or Inadequate Connection (4037)

Patient Problem Diabetic Ketoacidosis (2364)

Event Date 01/31/2021

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) years old pediatric male patient of unknown origin.Medical history and concomitant medication not provided.The patient received insulin lispro (humalog) via cartridge through re-usable humapen luxura half dose 3.5-5 units thrice daily subcutaneously for treatment of unknown indication beginning in 2013.He started using re-usable humapen luxura half dose in 2017.Approximately on (b)(6) 2021, he got into coma and taken into intensive care.The reason of coma that ketone was found in patients due high blood sugar, he did not receive insulin and because patient did not eat anything when he applied insulin.He stayed in intensive care for three days and one week in normal service of hospital.On an unknown date in (b)(6) 2021, he was discharged.No further information provided.Since on an unknown date, the head of the application humapen luxura hd pen was moving; (product complaint-(b)(4); lot-unknown); it was not stable and might be due to application pen was fallen earlier.Normally the application pen fell many times before, but there was no problem.The problem was in head of the application pen, there was no problem on dosage applying part.There was no cracked or broken part of the application pen after falling; patient received insulin with same application pen.In addition, they dropped and cracked 5-6 application pens before as well and the problem with application pen was about their selves.Information regarding further corrective treatment and outcome of event was not provided.Insulin lispro treatment was continued.The operator of the reusable humapen luxura half dose device was father of the patient and his training status was not provided.The general reusable humapen luxura half dose device model duration of use started in 2017 and suspect reusable humapen luxura half dose device duration of use was not provided.The suspect device was discarded and device return was expected.The reporting consumer did not provide the relatedness between event and insulin lispro treatment and humapen luxura half dose device but considered coma and ketone related to.High blood sugar.Edit (b)(6) 2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 25-mar-2021: information was received on 22-mar-2021 from the responsible contact person (rcp) provided the product complaint (pc) reference number (b)(4) and pc was processed accordingly.No medically significant information was added.No further changes were done to the case.

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 11-years old pediatric male patient of unknown origin.Medical history and concomitant medication not provided.The patient received insulin lispro (humalog) via cartridge through re-usable humapen luxura half dose 3.5-5 units thrice daily subcutaneously for treatment of unknown indication beginning in 2013.He started using re-usable humapen luxura half dose in 2017.Approximately on (b)(6) 2021, he got into coma and taken into intensive care.The reason of coma that ketone was found in patients due high blood sugar, he did not receive insulin and because patient did not eat anything when he applied insulin(conflicting).He stayed in intensive care for three days and one week in normal service of hospital.On an unknown date in (b)(6) 2021, he was discharged.No further information provided.Since on an unknown date, the head of the application humapen luxura hd pen was moving; (product complaint (b)(4); lot unknown); it was not stable and might be due to application pen was fallen earlier.Normally the application pen fell many times before, but there was no problem.The problem was in head of the application pen, there was no problem on dosage applying part.There was no cracked or broken part of the application pen after falling; patient received insulin with same application pen.In addition, they dropped and cracked 5-6 application pens before as well and the problem with application pen was about their selves.Information regarding further corrective treatment and outcome of event was not provided.Insulin lispro treatment was continued.The operator of the reusable humapen luxura half dose device was father of the patient and his training status was not provided.The general reusable humapen luxura half dose device model duration of use started in 2017 and suspect reusable humapen luxura half dose device duration of use was not provided.The humapen luxura half dose (unknown lot) associated with product complaint (b)(4) was not returned to the manufacturer.The reporting consumer did not provide the relatedness between event and insulin lispro treatment and humapen luxura half dose device but considered coma and ketone related to.High blood sugar.Edit 24mar2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 25-mar-2021: information was received on 22-mar-2021 from the responsible contact person (rcp) provided the product complaint (pc) reference number (b)(4) and pc was processed accordingly.No medically significant information was added.No further changes were done to the case.Update 13apr2021: additional information received on 13apr2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information for the humapen luxura half dose (unknown lot) associated with product complaint (b)(4) which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

No further follow-up is planned.Evaluation summary: a consumer reported on behalf of a male patient that the "head of the application humapen luxura hd pen was moving" and "it was not stable and might be due to application pen was fallen earlier." the reporter stated "the problem was in head of the application pen, there was no problem on dosage applying part.There was no cracked or broken part of the application pen after falling; patient received insulin with same application pen." the patient experienced diabetic ketoacidosis.The device was not returned to the manufacturer for investigation (batch 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 and dose accuracy with high probability.The core instructions for use states to always carry a spare insulin pen in case your pen is lost or damaged.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
• MDR Report Key: 11614570
• MDR Text Key: 260674240
• Report Number: 1819470-2021-00049
• 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: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• 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
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 11 YR