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

Model Number MS9662

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Deliver (2338); Physical Resistance/Sticking (4012)

Patient Problems Hyperglycemia (1905); Underdose (2542)

Event Type  Injury  

Manufacturer Narrative

New, updated and corrected information is referenced within the update statements.Please refer to update statement(s) dated 01oct2019.No further follow-up is planned.Evaluation summary: a female patient reported that the injection button of her humapen luxura device could not inject insulin smoothly and became stuck during injection.She reported the injection dose was not exact due to the injection problems.She experienced increased blood glucose.The device was not returned for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.However, the diabetes educator reported that the issue was resolved.All humapen luxura devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.The patient also reported that she did not prime the device before every injection.The core instructions for use states to prime the device using 2 units before every injection until insulin is seen at the needle tip.There is evidence of improper use.The user did not prime the device before each injection.This may be relevant to the event of increased blood glucose.

Event Description

This spontaneous case, reported by a consumer who contacted the company to report adverse events and a product complaint (pc), concerned a female patient of unknown age and origin.Medical history, previous drug adverse reaction, family drug adverse reaction and concomitant medications were not provided.The patient received an unspecified insulin, via a reusable humapen luxura (burgundy reported as purple) pen, at an unknown dose and frequency subcutaneously for the treatment of diabetes mellitus beginning on an unknown date.On (b)(6) 2019 the injection button of an insulin injection humapen luxura burgundy could not inject insulin into the body smoothly the dose of 10 units was dialed when she injected 6 units it was got stuck then she pressed down 2 units, it was stuck again and the again pressed down 2 units again however the full dose could be received afterwards and further she could not injected insulin due to humapen luxura burgundy issue ((b)(4); lot: unknown).Further, due to humapen luxura burgundy issue, the dose could not injected her blood glucose got high (values, units and reference range not provided) for which she was hospitalized to regulate the blood glucose.The injection dose (insulin) was not exact due to injection humapen luxura burgundy problems.She also did not prime before every injection which was considered to be improper use and was holding for several seconds after injection completed.Information regarding further hospitalization details, corrective treatments, outcome of the events and status of unspecified insulin was not provided.The user of the humapen luxura burgundy was the patient and her training status was not provided.The general model humapen luxura burgundy duration of use was not provided and the suspect humapen luxura burgundy duration of use was two days as it was started in (b)(6) 2019.The suspect humapen luxura burgundy device was continued as the diabetic educator reported that the issue had been resolved.The suspect device was not returned to the manufacturer.The reporting consumer related the events of accidental underdose and incorrect dose administered to the humapen luxura burgundy device issue whereas did not provide relatedness assessment between the remaining event and humapen luxura burgundy device.Update 12-sep-2019: this case was determined to be non valid as there was no identifiable valid suspect product reported.Update 16-sep-2019: this case was initially determined to be non-valid (no identifiable valid suspect product).Additional information received from the initial reporter on 10-sep-2019, which contained valid device as suspect.This case was upgraded to serious due to non-serious event of blood glucose increased was upgraded to serious with hospitalization.Added humapen luxura burgundy as suspect device.Updated narrative with new information.Update 23-sep-2019: additional information was received from the initial reporting consumer on 19-sep-2019.Added one non-serious event of incorrect dose administered.Updated causality statement and narrative with new information.Update 01oct2019: additional information received on 01oct2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information, malfunction from unknown to no, and device return status to not returned to manufacturer for (b)(4) associated with an unknown lot of humapen luxura (burgundy) device.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN LUXURA BURGUNDY
• 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: 9151596
• MDR Text Key: 167806976
• Report Number: 1819470-2019-00176
• 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: company representative,consum
• Type of Report: Initial
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9662
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2019
• 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