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

Model Number MS9673A

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Insufficient Flow or Under Infusion (2182); Output Problem (3005)

Patient Problem Hyperglycemia (1905)

Event Date 04/30/2021

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 spontaneous case, reported by a consumer who contacted the company to report adverse events and a product complaint (pc), concerned a (b)(6) female patient of an unknown ethnicity.Medical history and concomitant medications were not provided.The patient received insulin lispro (rdna origin) injections (humalog 100), from cartridge via a reusable device humapen luxura half-dose (hd), at an unknown dose and frequency subcutaneously for the treatment of diabetes mellitus, beginning on an unknown date in (b)(6) 2020.Since an unknown date, while on insulin lispro therapy, humapen luxura hd pen got impaired as it leaked insulin upon adjusting the dose.Due to humapen luxura hd pen impairment, she did not get the full dose.Due to this, her blood glucose level was very high i.E.500 mg/dl (reference range not provided) due to which she was hospitalized for two days in (b)(6) 2021 (batch number: unknown and pc number: (b)(4)).Information regarding corrective treatment and outcome of the events was unknown.Status of insulin lispro therapy was continued.The operator of humapen luxura hd and his/her training status were not provided.The general humapen luxura hd duration and suspect humapen luxura hd duration was approximately four months as it was started in (b)(6) 2020.Action taken with humapen luxura hd was not provided and its return was expected.The initial reporting consumer did not provide the relatedness assessment of the events with insulin therapy while considered that the events were related to humapen luxura hd.Edit 04may2021: updated medwatch and european and (b)(4) (eu/(b)(4)) fields for expedited device reporting.No new information added.

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 21may2021 in the b.5.Field.No further follow-up is planned.Evaluation summary: a consumer reported on behalf of a female patient that the patient's humapen luxura hd device leaked insulin upon adjusting the dose, and she did not get the full dose.The patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch unknown).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.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.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and a product complaint (pc), concerned a 2-year-old female patient of an unknown ethnicity.Medical history and concomitant medications were not provided.The patient received insulin lispro (rdna origin) injections (humalog 100), from cartridge via a reusable device humapen luxura half-dose (hd), at an unknown dose and frequency subcutaneously for the treatment of diabetes mellitus, beginning on an unknown date in (b)(6) 2020.Since an unknown date, while on insulin lispro therapy, humapen luxura hd pen got impaired as it leaked insulin upon adjusting the dose.Due to humapen luxura hd pen impairment, she did not get the full dose.Due to this, her blood glucose level was very high i.E.500 mg/dl (reference range not provided) due to which she was hospitalized for two days in (b)(6) 2021 (batch number: unknown and pc number: (b)(4)).Information regarding corrective treatment and outcome of the events was unknown.Status of insulin lispro therapy was continued.The operator of humapen luxura hd and his/her training status were not provided.The general humapen luxura hd duration and suspect humapen luxura hd duration was approximately four months as it was started in (b)(6) 2020.Action taken with humapen luxura hd was not provided.The suspect humapen luxura hd pen (unknown lot) associated with product complaint (b)(4) was not returned to the manufacturer.The initial reporting consumer did not provide the relatedness assessment of the events with insulin therapy while considered that the events were related to humapen luxura hd.Edit 04may2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 21may2021: additional information received on 20may2020 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 and added unique identifier information for the humapen luxura hd pen (unknown lot) associated with product complaint (b)(4) which was not returned to the manufacturer.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
• MDR Report Key: 11784122
• MDR Text Key: 262192156
• Report Number: 1819470-2021-00067
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• 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
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 2 YR