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

Model Number MS9673A

Device Problems Break (1069); Mechanical Problem (1384); Detachment of Device or Device Component (2907); Mechanical Jam (2983)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Manufacturer Narrative

If device is returned, evaluation will be performed to determine if a malfunction has occurred.A follow-up report will be submitted when the final evaluation is completed as necessary.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via patient support program (psp), concerned an (b)(6) years-old male patient of unknown origin.Medical history was not provided.Concomitant medications included insulin glargine for the treatment of unknown indication.The patient received insulin lispro (rdna origin) injections (humalog) from a cartridge via unknown device, with unknown dose and route, three times a day for type 1 diabetes, beginning on (b)(6) 2018.On an unknown date in 2019 (used for 1.5 years- as reported), he started to receive insulin lispro via a reusable humapen luxura hd (half dose) (unknown color).Since an unknown date, he had pain with needle tips (accu fine).The pharmacist stated that it could be psychological since all types of needle tips were in same size and thickness.Accu fine was used in his first hospitalization which was the time that he was firstly diagnosed (unspecified).They were trying to find best solution for him to manage this situation well.Bd microfine needle was advised on pharmacy and the consumer bought bd microfine.On (b)(6) 2020, he was hospitalized due to blood glucose level elevations.He did not remember how high his blood sugar level was when he was hospitalized.He was discharged from hospital on (b)(6) 2020.The needle tips that used in hospitalization duration caused pain to him.When he thought that the blood glucose measured as high, the blood glucose was actually elevated in that time because of the failure of glucose meter.On (b)(6) 2021, the humapen luxura hd pen was damaged, it was jammed, and they requested a new pen (product compliant# (b)(4), lot# 1709g03).He was especially using accu-fine needle tip and the other types of needle tip caused pain.Information regarding further corrective treatment and outcome of the events was not provided.Status of insulin lispro therapy was unknown.The operator of the reusable humapen luxura hd device and his/her training status was not provided.The general reusable humapen luxura hd device model duration of use was unknown and the suspect device duration of use was 1.5 years.The action taken with status of suspect reusable humapen luxura hd device was unknown and its return status was not provided.The reporting consumer did not provide relatedness assessment between the events and insulin lispro drug and humapen luxura hd device.Update 13-jan-2021: initial information received on 07-jan-2021 and follow up information received on 11-jan-2021 was processed together.Edit 14jan2021: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.Upon review, added suspect device age accordingly.Edit 15jan2021: the unique device identifier ((b)(4)) for the humapen luxura half-dose device was added for expedited device reporting.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via patient support program (psp), concerned an 11-years-old male patient of unknown origin.Medical history was not provided.Concomitant medications included insulin glargine for the treatment of unknown indication.The patient received insulin lispro (rdna origin) injections (humalog) from a cartridge via unknown device, with unknown dose and route, three times a day for type 1 diabetes, beginning on (b)(6) 2018.On an unknown date in 2019 (used for 1.5 years- as reported), he started to receive insulin lispro via a reusable humapen luxura hd (half dose) (unknown color).Since an unknown date, he had pain with needle tips (accu fine).The pharmacist stated that it could be psychological since all types of needle tips were in same size and thickness.Accu fine was used in his first hospitalization which was the time that he was firstly diagnosed (unspecified).They were trying to find best solution for him to manage this situation well.Bd microfine needle was advised on pharmacy and the consumer bought bd microfine.On (b)(6) 2020, he was hospitalized due to blood glucose level elevations.He did not remember how high his blood sugar level was when he was hospitalized.He was discharged from hospital on (b)(6) 2020.The needle tips that used in hospitalization duration caused pain to him.When he thought that the blood glucose measured as high, the blood glucose was actually elevated in that time because of the failure of glucose meter.On (b)(6) 2021, the humapen luxura hd pen was damaged, it was jammed, and they requested a new pen (product complaint (b)(4), lot 1709g03).He was especially using accu-fine needle tip and the other types of needle tip caused pain.Information regarding further corrective treatment and outcome of the events was not provided.Status of insulin lispro therapy was unknown.The operator of the reusable humapen luxura hd device and his/her training status was not provided.The general reusable humapen luxura hd device model duration of use was unknown and the suspect device duration of use was 1.5 years.The suspect device, which was manufactured in sep2017, was returned to the manufacturer on 19jan2021.The reporting consumer did not provide relatedness assessment between the events and insulin lispro drug and humapen luxura hd device.Update 13-jan-2021: initial information received on 07-jan-2021 and follow up information received on 11-jan-2021 was processed together.Edit 14jan2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Upon review, added suspect device age accordingly.Edit 15jan2021: the unique device identifier ((b)(4)) for the humapen luxura half-dose device was added for expedited device reporting.Update 01apr2021: additional information received on 01apr2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information, malfunction from unknown to yes/not cirm, and device return status to returned to manufacturer.Added date of manufacturer and date returned to manufacturer for the device for (b)(6) associated with lot 1709g03 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 01apr2021 in the b.5.Field.No further follow-up is planned.Evaluation summary.On 07-jan-2021, the father of the patient stated the "dose setting part" of humapen luxura hd device malfunctioned.He stated "there was no sound when setting the dose," and "the white part, that unit number was written, dislocated." on (b)(6) 2020, the patient experienced increased blood glucose.Investigation of the returned device (batch 1709g03, manufactured september 2017) found the device did not click when dialed, and the dial became detached from the injection screw, with minimal force applied.The issue was found to be associated with the glue bond between the dial and dialing screw.Malfunction confirmed.An investigation of the returned device confirmed the presence of all components and evidence of glue in all four glue wells and in the racetrack.The presence of glue in the glue wells and the racetrack suggests that the glue was dispensed in the correct location and wicked to the anticipated areas of the device during manufacturing.A complaint history review and a batch record review for the device batch did not identify any atypical findings with respect to broken device issues.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.Although a malfunction was confirmed, the malfunction occurred approximately eight months after the report of increased blood glucose, which indicates the malfunction was not likely responsible for the increased blood glucose.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: 11177210
• MDR Text Key: 232802628
• Report Number: 1819470-2021-00006
• 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: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• 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: 1709G03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Date Manufacturer Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 11 YR