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

Model Number MS9694

Device Problem Mechanical Problem (1384)

Patient Problem Hyperglycemia (1905)

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 spontaneous case, reported by a nurse with product complaint via a sales representative, concerns a female patient of unknown age.The patient did not have medical history.Her concomitant medication included insulin glargine.On unknown date, the patient started subcutaneous insulin lispro (humalog cart) via a humapen savvio (lot#1704v03) for type 1 diabetes mellitus (dose and frequency not provided).On unknown date, unknown duration after starting insulin lispro and after starting humapen savvio, the gap between the plunger and cartridge of the humapen savvio became wider during usage by inserting the cartridge into the device, then she developed minor hyperglycaemia.This case is associated with (b)(4).Insulin lispro was continued.On unknown date, she recovered from hyperglycaemia.Information regarding treatment information was not provided.The operator of the pen was the patient and she was trained user.The general duration of model use and the duration of suspect device model use were not provided.The pen was returned on 20-jan-2020 and detail investigating in progress.The reporting nurse considered the event was related to the failure of device and the patients underlying disease.Information received on 20-jan-2020 from global product complaint system was processed together with the initial report.Edit 10feb2020: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.

Manufacturer Narrative

Narrative field; new updated and corrected information is referenced within the update statements in event description.Please refer to statement dated 06mar2020 in the event description field.No further follow up is planned.Evaluation summary a nurse reported on behalf of a female patient that the gap between the plunger and cartridge of the patient's humapen savvio became wider during usage by inserting the cartridge into the device.The patient experienced non-serious hyperglycemia.Investigation of the returned device (batch 1704v03, april 2017) identified a broken bulkhead component, and found an oily substance present on the housing collar near the bulkhead subassembly.Spectroscopic analysis of the oily substance identified it to be consistent with a fatty acid based substance.The fatty acid based substance, introduced in the field and not related to the manufacturing process, caused degradation of the bulkhead component, causing the device malfunction.Malfunction confirmed.The core user manual provides instructions for proper care and storage of the device.It states, "do not use alcohol, hydrogen peroxide or bleach on the pen body or dose window.Also, do not cover in liquid or apply lubrication such as oil, as this could damage the pen." there is evidence of improper use.Foreign material contamination of the device occurred while in the field (not related to the manufacturing process).This misuse is relevant to the finding of bulkhead failure and may be relevant to the non-serious event of hyperglycemia.

Event Description

Lilly case id: (b)(4).This spontaneous case, reported by a nurse with product complaint via a sales representative, concerns a female patient of unknown age.The patient did not have medical history.Her concomitant medication included insulin glargine.On unknown date, the patient started subcutaneous insulin lispro (humalog cart) via a humapen savvio (lot#1704v03) for type 1 diabetes mellitus (dose and frequency not provided).On unknown date, unknown duration after starting insulin lispro and after starting humapen savvio, the gap between the plunger and cartridge of the humapen savvio became wider during usage by inserting the cartridge into the device, then she developed minor hyperglycaemia.This case is associated with pc#(b)(4).Insulin lispro was continued.On unknown date, she recovered from hyperglycaemia.Information regarding treatment information was not provided.The operator of the pen was the patient and she was trained user.The general duration of model use and the duration of suspect device model use were not provided.The pen was returned on 20-jan-2020 and detail investigating in progress.The reporting nurse considered the event was related to the failure of device and the patients underlying disease.Information received on 20-jan-2020 from global product complaint system was processed together with the initial report.Edit 10feb2020: updated medwatch and european and (b)(4) fields for expedited device reporting.No new information added.Updated on 18-feb-2020: additional information was received on 17-feb-2020 from the reporting nurse via the sales representative.Added drug dosage and start date of humapen savvio as general model and suspect device.Changed reporters causality opinions.Corresponding fields and narrative were updated.Updated on 06-mar-2020: additional information was received on 27-feb-2020 and 01-mar-2020 from the global product complaint database.Added device specific safety summary.Changed improper use and storage from no to yes.Corresponding fields and narrative updated accordingly.Edit 16mar2020: updated medwatch fields for expedited device reporting.No new information added.

• Brand Name: HUMAPEN SAVVIO 3ML (RED)
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis, in
• Manufacturer (Section G): TECH GROUP NORTH AMERICA INC. DBA WEST; 640 south rockford drive; tempe, az
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, in ; 4334585
• MDR Report Key: 9707581
• MDR Text Key: 199990316
• Report Number: 1819470-2020-00016
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K160668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS9694
• Device Lot Number: 1704V03
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/20/2020
• Date Manufacturer Received: 02/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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