MAUDE Adverse Event Report: ELI LILLY AND COMPANY, PHARMACEUTICAL DELIVERY SYSTEMS HUMALOG QUICK PEN; SYRINGE, PISTON

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 12/02/2020

Event Type  Injury  

Event Description

Caller reported that on (b)(6) 2020 she injected her pen needle and noticed that while removing the needle it leaked.She tried with two other needles and they both leaked.She then noticed that the pad that holds the chamber is depressed more than it should be.She further stated that the device is defective and has a mechanical issue.

Event Description

Additional information received from reporter on 12/03/2020 for report number mw5097426.Reporter stated that she is still experiencing problems with the humalog pen particularly the injector.In this case it is case.She has to apply force and re-apply force before it can work.

• Brand Name: HUMALOG QUICK PEN
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): ELI LILLY AND COMPANY, PHARMACEUTICAL DELIVERY SYSTEMS
• MDR Report Key: 10726198
• MDR Text Key: 213047009
• Report Number: MW5097426
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 12/03/2020
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2022
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 82