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

Model Number MS9673A

Device Problems Insufficient Flow or Under Infusion (2182); Mechanical Jam (2983)

Patient Problems Hyperglycemia (1905); Coma (2417)

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) year-old male patient with an unknown origin.Medical history and concomitant medications were not provided.The patient received insulin lispro (rdna origin) injections (humalog), from cartridge via a reusable device humapen luxura half-dose, at an unknown dose and frequency via an unknown route for the treatment of an unknown indication, beginning on an unknown date.He had been using humapen luxura half-dose pen since (b)(6) 2019.On an unknown date, while on insulin lispro therapy, the head of humapen luxura half-dose pen was not pressed due to which he received insulin insufficiently (batch number: 1606g08 and pc number: (b)(4)).Due to his, he was almost going into coma (as reported).The event possible diabetic coma was considered as serious due to medical significance reason.Information regarding corrective treatment, events outcome and status of insulin lispro therapy was not provided.Follow up was not possible as the reporter did not provide the consent for further contact.The operator of humapen luxura half-dose and his/her training status were not provided.The general humapen luxura half-dose duration was not provided and suspect humapen luxura half-dose duration was approximately two years as it was started in (b)(6) 2019.The status of humapen luxura half-dose was not provided and its return was not expected.The initial reporting consumer did not provide the relatedness assessment of the events with insulin lispro therapy.The initial reporting consumer considered that the event of incorrect dose administered was related to humapen luxura half-dose device issue and did not provide the relatedness assessment of the remaining event with humapen luxura half-dose.Update 15-feb-2021: information received on 10-feb-2021 and 12-feb-2021 were processed together.Edit 22feb2021: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.Edit 23-feb-2021: upon review, updated degree of harm of the event incorrect dosage administered.No new information added and no other changes were made to the case.Edit 23-feb-2021: added udi number of (b)(4) on suspect device tab.

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 15-year-old male patient with an unknown origin.Medical history and concomitant medications were not provided.The patient received insulin lispro (rdna origin) injections (humalog), from cartridge via a reusable device humapen luxura half-dose, at an unknown dose and frequency via an unknown route for the treatment of an unknown indication, beginning on an unknown date.He had been using humapen luxura half-dose pen since (b)(6) 2019.On an unknown date, while on insulin lispro therapy, the head of humapen luxura half-dose pen was not pressed due to which he received insulin insufficiently (batch number: 1606g08 and pc number: (b)(4)).Due to his, he was almost going into coma (as reported).The event possible diabetic coma was considered as serious due to medical significance reason.Information regarding corrective treatment, events outcome and status of insulin lispro therapy was not provided.Follow up was not possible as the reporter did not provide the consent for further contact.The operator of humapen luxura half-dose and his/her training status were not provided.The general humapen luxura half-dose duration was not provided and suspect humapen luxura half-dose duration was approximately two years as it was started in (b)(6) 2019.The humapen luxura half-dose associated with product complaint (b)(4) (lot 1606g08) was returned to the manufacturer on 02mar2021.The initial reporting consumer did not provide the relatedness assessment of the events with insulin lispro therapy.The initial reporting consumer considered that the event of incorrect dose administered was related to humapen luxura half-dose device issue and did not provide the relatedness assessment of the remaining event with humapen luxura half-dose.Update 15-feb-2021: information received on 10-feb-2021 and 12-feb-2021 were processed together.Edit 22feb2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 23-feb-2021: upon review, updated degree of harm of the event incorrect dosage administered.No new information added and no other changes were made to the case.Edit 23-feb-2021: added udi number of (b)(4) on suspect device tab.Update 11-mar-2021: additional information was received from the affiliate after review of information received on 10-feb-2021.Added the height and weight of the patient.No other changes were made to the case.Update 09apr2021: additional information received on 06apr2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information, the european and canadian (eu/ca) device information, malfunction from unknown to no, and device return status to returned to manufacturer.Added date of manufacturer and date returned to manufacturer for the humapen luxura half-dose associated with product complaint (b)(4) (lot 1606g08).Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

This is a downgrade report which no longer meets the criteria for expedited reporting.No further follow-up is planned.Evaluation summary: the mother of a male patient reported that the injection button of the patient's humapen luxura hd device could not be pressed, and the patient did not receive sufficient insulin.The patient experienced diabetic coma.Investigation of the returned device (batch 1606g08, manufactured june 2016) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.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: 11364745
• MDR Text Key: 242281892
• Report Number: 1819470-2021-00034
• 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: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• 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: 1606G08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 15 YR