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

Model Number MS9662

Device Problem Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Loss of consciousness (2418)

Event Date 01/31/2010

Event Type  Injury  

Event Description

Lilly case id: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event, concerned a male patient of unknown age, and origin.Medical history included diabetic since 1993.Concomitant medications were not provided.The patient had no history of pancreatitis.The patient received insulin lispro (rdna origin) injection (humalog) cartridge and human insulin isophane suspension (rdna origin) injection (humulin n) cartridge; both via reusable pens (humapen luxura, burgundy), at an unknown dose and frequency, via an unknown route of administration, for the treatment of diabetes, beginning on an unknown date.On an unknown date in 2010, while on insulin lispro and human insulin isophane suspension therapies, he experienced hyperglycemia with loss of consciousness and mental confusion and was hospitalized.Reportedly, he was using humapen luxura, burgundy over ten years.Information regarding corrective treatment, outcome of the events and status of insulin lispro and human insulin isophane suspension therapies was not provided.The operator of the humapen luxura, burgundy was the patient and his training status was not provided.The general humapen luxura, burgundy duration of use was not provided.The suspect humapen luxura, burgundy duration of use was of over ten years.The action taken with humapen luxura, burgundy was unknown, and its return was not expected.The initial reporting consumer did not provide the relatedness assessment between the events and insulin lispro and human insulin isophane suspension therapies and humapen luxura, burgundy device.This case was cross-referenced with the following cases, (b)(4) and (b)(4) (same patient).Update 20-jul-2023: initial and follow up information received on 14-jul-2023, 17-jul-2023 and 18-jul-2023, were processed together.Update 21jul2023: additional information received on 21jul2023 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields.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 statement dated (b)(6) 2023 in the b.5.Field.No further follow up is planned.Evaluation summary: the reporter stated the patient used the humapen luxura burgundy since approximately 2013.There was no product complaint for the device and the device was not returned for investigation.There was evidence of improper use of the device.The patient used the humapen luxura burgundy for approximately ten years.The humapen luxura burgundy user manual states to not use the pen for more than six years after the first use.

• 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: catherine cassidy ; lilly corporate center; indianapolis, IN 46285 ; 3174332191
• MDR Report Key: 17373462
• MDR Text Key: 319557022
• Report Number: 1819470-2023-00050
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K142518
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9662
• Device Lot Number: 1205B01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2023
• 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 Sex: Male