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

Model Number MS9662

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 01/31/2003

Event Type  Injury  

Event Description

Lilly case id: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events, concerned a male patient of unknown age and origin.Medical history included diabetic since 1993.Concomitant medications were not provided.The patient received insulin lispro (rdna origin) injection (humalog 100u/ml) from cartridge via humapen luxura burgundy, for the treatment of diabetes, beginning on an unspecified date in 2003.He had the humapen luxura burgundy pen for over 10 years (improper use).Dosage, route of administration and frequency of use were not provided.On an unknown date in 2003 or 2010 (conflicting date), while on insulin lispro therapy, the patient was hospitalized due to hypoglycemia presented with mental confusion and loss of consciousness.Information regarding the outcome of event, corrective treatment and further hospitalization details was not provided.Status of insulin lispro therapy was ongoing.The operator of the humapen luxura burgundy was the patient, and his training status was not provided.The device model duration of use and suspect device duration of use were not reported.The action taken with the suspect humapen luxura burgundy was not returned to the manufacturer.The initial reporting consumer did not report the relatedness assessment of the event with the insulin lispro therapy nor with humapen luxura burgundy device.This case is cross referenced with the following cases: (b)(4) and (b)(4) (same patient).Update (b)(6) 2023: information received on 29-sep-2023 from the initial reporter did not include medically significant information.No changes were made to the case.Edit (b)(6) 2023: upon review of information received on 14-jul-2023, improper use or storage field was updated from no to yes and added batch number of humapen luxura burgundy.Updated narrative accordingly.Update (b)(6) 2023: additional information received on 08nov2023 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 update statement(s) dated 08nov2023 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 2003.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 twenty 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 46285
• Manufacturer (Section G): PHILLIPS-MEDISIZE CORPORATION; medical device manufacturing; 415 red cedar street; menomonie 54751
• Manufacturer Contact: catherine cassidy ; lilly corporate center; indianapolis, IN 46285 ; 3174332191
• MDR Report Key: 18095062
• MDR Text Key: 327665415
• Report Number: 1819470-2023-00051
• 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: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• 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