MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA BURGUNDY; FOR TREATMENT PURPOSES

Model Number MS9662

Device Problems Mechanical Problem (1384); Failure to Deliver (2338); Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Reportable malfunction/incident identified.Investigation in progress.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 device case, which does not involve an adverse event, reported by a consumer who contacted the company with a product complaint (pc), concerns a patient of unspecified gender, age, and ethnicity.The patient was taking an unspecified medication via humapen luxura (burgundy device); indication for use and dosage regiment not provided.It was noted that the injection button on the humapen luxura (burgundy) was pushed down to the end directly without clicking sounds and the humapen luxura (burgundy) could not push insulin out on 27aug2020.This humapen luxura (burgundy) device was associated with product complaint (b)(4) /lot number 1106b03.On 31aug2020, the device was returned.Upon investigation the device was found to have barrel misalignment.Information on the user of device, their training status, model duration of use, and suspect device duration of use was not provided.The suspect humapen luxura (burgundy) device associated with product compliant (b)(4) was returned to the manufacturer on 31aug2020.22sep2020 update: additional information was received from the global product complaint database on 22sep2020.Reiterated product complaint (b)(4) with lot number 1106b03 relating to humapen luxura (burgundy) device.As a device specific safety summary was not provided, the malfunction and malfunction type was not updated 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 20oct2020 in the b.5.Field.No further follow-up is planned.Evaluation summary.Patient reported that injection button on humapen luxura device "was pushed down to the end directly without clicking sounds and could not push insulin out." the device issue was not associated with adverse event.Initial screening of the device associated the case with the reportable malfunction "barrel misalignment." investigation of the returned device (batch 1106b03/manufactured june2011) determined the device was not associated with this reportable malfunction.Investigation found dial sub-assembly misalignment in dial nut housing and damage to dialing screw threads.Malfunction confirmed.The damage was consistent with excessive torque being applied by the user, which caused dial sub-assembly to become detached and was reinserted by the user, causing the damage to the dialing screw threads.The lack of clicking sounds when dialing is a result of the damage to the device.In addition, an unknown foreign material was observed on the dialing screw.The investigation determined that the damage occurred in the field due to intentional misuse and was not associated with the manufacturing or assembly of the device.The core instructions for use provides the proper instructions for use and care of the device, and states if any of the part of your humapen luxura appears broken or damaged, do not use.The user manual further states to contact lilly or your healthcare professional for a replacement pen.While it is unknown how long the patient used the device, based on the amount of time elapsed since the device was manufactured (june 2011), it is likely the patient used it beyond its approved use life.The core instructions for use states the humapen luxura has been designed to be used for up to six years after first use.There is evidence of improper use.Patient likely used device beyond its approved use life.User applied excessive force,disassembled and reassembled the device, which caused damage/misalignment of device.Its likely that misuse caused device malfunction.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This device case, which does not involve an adverse event, reported by a consumer who contacted the company with a product complaint (pc), concerns a patient of unspecified gender, age, and ethnicity.The patient was taking an unspecified medication via humapen luxura (burgundy device); indication for use and dosage regiment not provided.It was noted that the injection button on the humapen luxura (burgundy) was pushed down to the end directly without clicking sounds and the humapen luxura (burgundy) could not push insulin out on (b)(6) 2020.This humapen luxura (burgundy) device was associated with product complaint (b)(4)/lot number 1106b03.On (b)(6) 2020, the device was returned.Upon investigation the device was found to have barrel misalignment.Information on the user of device, their training status, model duration of use, and suspect device duration of use was not provided.The suspect humapen luxura (burgundy) device associated with product compliant (b)(4) was returned to the manufacturer on 31aug2020.22sep2020 update: additional information was received from the global product complaint database on 22sep2020.Reiterated product complaint (b)(4) with lot number 1106b03 relating to humapen luxura (burgundy)device.As a device specific safety summary was not provided, the malfunction and malfunction type was not updated to no.Corresponding fields and narrative updated accordingly.Update 20oct2020: additional information received on 20oct2020 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information, improper use and storage from no to yes, and malfunction from yes/cirm to yes/not cirm.Added date of manufacturer for (b)(4) associated with lot 1106b03 of humapen luxura (burgundy) device.Corresponding fields and narrative updated accordingly.Update 21oct2020: additional information received on 21oct2020 rom the global product complaint database.No new information added.

• Brand Name: HUMAPEN LUXURA BURGUNDY
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 10655722
• MDR Text Key: 212765430
• Report Number: 1819470-2020-00117
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K142518
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9662
• Device Lot Number: 1106B03
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2020
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1