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

Model Number MS9662

Device Problem Fluid/Blood Leak (1250)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Type  Injury  

Manufacturer Narrative

No further follow-up is planned.Evaluation summary: a female patient reported that, on an unknown date in the past, her humapen luxura was leaking from the needle after the injection was completed.She experienced abnormal blood glucose (including hospitalization on an unknown date in 2017 and every year for regulating 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.Malfunction unknown.All humapen luxura devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.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 an adverse event, concerned a (b)(6) year-old (b)(6) nationality) female patient.Medical history included allergic to penicillin.Concomitant medications included glucobay used for an unknown indication.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog 50, 100 u/ml), through cartridge via reusable pens (humapen luxura burgundy and humapen ergo ii), twice daily (bid) (morning 10,night 10) subcutaneously for the treatment of diabetes mellitus beginning on an unknown date.On an unknown date, after starting insulin lispro protamine suspension 50%/insulin lispro 50% therapy, her blood glucose was unstable.On an unknown date in 2017, she had been hospitalized.She was hospitalized every year for regulating blood glucose.The humapen luxura burgundy occurred a leaking out of the needle when the injection was finished (the amount of the leakage was unknown).She had no requirement for humapen luxura burgundy as it had been replaced (b)(4), lot unknown).The humapen ergo ii occurred that there was two drops of insulin leaking out of the needle after the injection was finished during (b)(6) 2019 to (b)(6) 2019.And he/she changed a new needle before each injection and did not store the humapen with the needle attached, and stored the humapen in the box (b)(4), lot 1611d01).Further hospitalization and discharge details were unknown.Information regarding any corrective treatment and event outcome was not provided.Therapy status with insulin lispro protamine suspension 50%/insulin lispro 50% was ongoing.The operator of the humapens and his or her training status was unknown.The general model humapen luxura burgundy duration of use and the suspect humapen luxura burgundy duration of use was not provided.The general model humapen ergo ii duration of use and the suspect humapen ergo ii duration of use was approximately two years as it was started in (b)(6) 2017.The humapen luxura burgundy was discontinued in (b)(6) 2017 and was not returned to the manufacturer, action taken with humapen ergo ii, which was manufactured in nov2016, was ongoing and was not returned to the manufacturer.The reporting consumer did not know if the event was related with insulin lispro protamine suspension 50%/insulin lispro 50% treatment.The reporting consumer did not provide relatedness of the event with humapen luxura burgundy and humapen ergo ii.Edit 06-apr-2020: upon external review of information received on 23-mar-2020.Updated humapen unknown body type to humapen luxura burgundy, updated pc details in narrative, updated euca fields for humapen luxura burgundy.No other changes to the case has been done.Update 10apr2020: additional information received on 09apr2020 from the global product complaint database.Entered device specific safety summaries (dsss).Updated the medwatch fields/ (b)(6) device information, and device return status to not returned to manufacturer for (b)(4) associated with unknown lot of a humapen luxura (burgundy) device and for (b)(4) associated with lot 1611d01 of humapen ergo ii device.Added date of manufacturer for (b)(4) associated with lot 1611d01 of humapen ergo ii device.Corresponding fields and narrative updated accordingly.Update 13apr2020: additional information received on 13apr2020 from the global product complaint database.No new information was added.Update 16apr2020: additional information received on 16apr2020 from the global product complaint database.No new information was added.

• Brand Name: HP LUXURA, BURGUNDY
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis,
• Manufacturer (Section G): PHILLIPS-MEDISIZE CORPORATION; 415 red cedar street; medical device manufacturing; menomonie,
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, in
• MDR Report Key: 9988540
• MDR Text Key: 193955500
• Report Number: 1819470-2020-00036
• 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: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Model Number: MS9662
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/23/2020
• Initial Date FDA Received: 04/22/2020
• 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
• Patient Age: 65 YR
• Patient Weight: 63