MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN SAVVIO 3ML (BLUE); FOR TREATMENT PURPOSES

Model Number MS9695

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Reportable malfunction/incident identified.Investigation in progress.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 device case, which does not include an adverse event, reported by a pharmacist who contacted the company with a product complaint, concerns a patient of unknown age, gender and ethnicity.The patient was taking human insulin (rdna origin) nph (humulin nph) cartridges, via a humapen savvio blue with the route, frequency, indication for use, and start date not provided.On an unspecified date it was stated that pharmacist wanted to order a new pen for the patient as pen was not working.This device was associated with product complaint (b)(4)./lot number 2005s02.The operator of the device was the patient and training status was unknown.The duration of use for the device model was unknown the device was returned to the manufacturer on 25jan2024.

• Brand Name: HUMAPEN SAVVIO 3ML (BLUE)
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis 46285
• Manufacturer (Section G): TECH GROUP NORTH AMERICA INC. DBA WEST; 640 south rockford drive; tempe AZ 85281
• Manufacturer Contact: catherine cassidy ; lilly corporate center; indianapolis, IN 46285 ; 3174332191
• MDR Report Key: 18696961
• MDR Text Key: 336411926
• Report Number: 1819470-2024-00008
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K160668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9695
• Device Lot Number: 2005S02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: No
• 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