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

Model Number MS9673A

Device Problem Mechanical Jam (2983)

Patient Problems Hyperglycemia (1905); Coma (2417)

Event Date 06/09/2021

Event Type  Injury  

Manufacturer Narrative

New, updated, and corrected information is referenced within the update statements.Please refer to update statement(s) dated 07jul2021.No further follow-up is planned.Evaluation summary a female patient reported that on (b)(6) 2021, her humapen luxura hd device "got impaired, became very heavy to press, and was releasing the insulin dose drop by drop." on (b)(6) 2021, she experienced hyperglycemia.The device was not returned to the manufacturer for investigation (batch number 1201g07, manufactured january 2012).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.A complaint history review did not identify any atypical findings with regard to injection force high or pen jam issues, and the batch threshold review did not identify any atypical findings with regard to dose accuracy issues.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 patient support program (psp), concerned a (b)(6)-years-old female patient with an unknown origin.Medical history and concomitant medication was not provided.The patient received insulin lispro (rdna origin) injections (humalog 100) from cartridge via a reusable humapen (luxura), for the treatment of diabetes mellitus beginning on an unknown date.Information regarding dosage regimen and route of administration were not provided.She was using humapen since (b)(6) 2018 or (b)(6) 2019 (exact start date was not reported).Since (b)(6) 2021, after starting insulin lispro therapy, she had fever, therefore insulin was not absorbed by her body (her body refused it), which led to high blood glucose levels and she was hospitalized since five days due to hyperglycemic coma and fever (units, value and reference range were not provided).She was now on unknown iv infusions.On (b)(6) 2021, her humapen got impaired, became very heavy to press, and was releasing the insulin dose drop by drop (pc (b)(4)/lot 1201g07).She tried changing the needle and cartridge but nothing changed as the humapen was still stuck.Therefore, since (b)(6) 2021, she had been using insulin lispro (rdna origin) injections (humalog) via a pre-filled pen (kwikpen) for the treatment of diabetes mellitus.Information regarding further corrective treatment, hospitalization details and outcome of the events was not provided.Insulin lispro (humalog cartridge) therapy status after discontinuation was not provided.The operator of humapen was unknown and his or her training status was not provided.The general humapen model duration and suspect humapen duration of use was not provided but it was started two or three years ago (since (b)(6) 2018 or (b)(6) 2019, exact start date was not reported).The suspect device manufactured in jan2012, was not returned to the manufacturer.The reporting consumer did not provide an assessment of relatedness between the event malabsorption from injection site and insulin lispro drug while assessed the relatedness between the remaining events and insulin lispro drug as unknown.The reporting consumer did not provide an assessment of relatedness between the events and humapen device.Edit 24jun2021: updated medwatch fields for expedited device reporting.No new information added.Update 07jul2021: additional information received on 02jul2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and (b)(6) device information and device return status not to returned to manufacturer.Added date of manufacturer for pc (b)(4) associated with 1201g07 of humapen luxura hd device.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: 12165877
• MDR Text Key: 261458127
• Report Number: 1819470-2021-00084
• 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
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• 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: 1201G07
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2021
• 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): Hospitalization
• Patient Age: 14 YR