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

Model Number MS9673A

Device Problems Break (1069); Failure to Deliver (2338); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Hyperglycemia (1905)

Event Date 01/19/2021

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 an (b)(6) year-old male patient of unspecified ethnicity.Medical history and concomitant medications was not provided.The patient received insulin lispro (rdna origin) (humalog 100u/ml) via cartridge formulation, through a reusable device humapen luxura hd (half dose), subcutaneously, beginning approximately in (b)(6) 2020 (as reported for 10 months).Dosage regimen and indication for use was not provided.Since an unknown date, humapen luxura hd did not release insulin for one week and he did not received insulin due to this (pc# (b)(4) lot#1808g01).On (b)(6) 21, his blood glucose was elevated on 500 (units and reference ranges were not provided) and he was hospitalized.On (b)(6) 21, he was discharged.Further information regarding corrective treatment and outcome of events unknown.As of (b)(6) 21, therapy status of insulin lispro was discontinued due to broken pen.It was unknown therapy would be restarted.Follow would not be possible as reporter chooses not to be contacted further for additional information and hcp contact information was not provided.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 approximately 10 months as it was started approximately in (b)(6) 2020.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 of events with insulin lispro treatment and did relate the events with suspect device humapen luxura hd.Edit (b)(6) 2021: updated medwatch and (b)(4) fields for expedited device reporting.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 an 11-year-old male patient of unspecified ethnicity.Medical history and concomitant medications was not provided.The patient received insulin lispro (rdna origin) (humalog 100u/ml) via cartridge formulation, through a reusable device humapen luxura hd (half dose), subcutaneously, beginning approximately in (b)(6) 2020 (as reported for 10 months).Dosage regimen and indication for use was not provided.Since an unknown date, humapen luxura hd did not release insulin for one week and he did not received insulin due to this (pc (b)(4)/lot number 1808g01).On (b)(6) 2021, his blood glucose was elevated on 500 (units and reference ranges were not provided) and he was hospitalized.On (b)(6) 2021, he was discharged.Further information regarding corrective treatment and outcome of events unknown.As of (b)(6) 2021, therapy status of insulin lispro was discontinued due to broken pen.It was unknown therapy would be restarted.It was noted that bd microfine needle tip was being used and there was no crashing or falling down at pen.Furthermore, there was no needle tip on the current pen; information related to usage of needle tip was provided, the needle attaching point was controlled, and it was noted that there was a swelling.Troubleshooting was performed via attaching a needle tip after setting the dose as 6 iu; however, the pen did not give drug.Follow would not be possible as reporter chooses not to be contacted further for additional information and hcp contact information was not provided.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 approximately 10 months as it was started approximately in (b)(6) 2020.It was noted that the pen was requested and a new pen was sent; however, the humapen luxura hd associated with product complaint (b)(4) was not returned to the manufacturer.The reporting consumer did not provide relatedness of events with insulin lispro treatment and did relate the events with suspect device humapen luxura hd.Edit 27jan2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 24feb2021: additional information received on 24feb2021 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.Added date of manufacturer for the suspect humapen luxura hd device associated with product complaint (b)(4), which was not returned to the manufacturer.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 dated 24feb2021 in the b.5.Field.No further follow-up is planned.Evaluation summary: the father of a male patient reported that his son's humapen luxura hd device did not release insulin for one week.The patient experienced increased blood glucose.Troubleshooting of the device by the call center was not successful.The device was not returned to the manufacturer for investigation (batch number 1808g01, manufactured august 2018).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.Based on the complaint narrative stating "the needle attaching point was controlled, he said there was a swelling," the cartridge might have been pressurized, causing a bulging septum.This would be an indication that dosing attempts were made without a needle attached or the needle not correctly attached.A complaint history review for the device batch did not identify any atypical findings with regard to device not working issues.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: 11259449
• MDR Text Key: 232638089
• Report Number: 1819470-2021-00019
• 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: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• 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: 1808G01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 11 YR