MAUDE Adverse Event Report: ELI LILLY AND COMPANY, PHARMACEUTICAL DELIVERY SYSTEMS TRULICITY INJECTOR PEN (BOX OF 4); INJECTOR, PEN

Device Problems Mechanical Problem (1384); Failure to Deliver (2338)

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

Event Date 05/30/2022

Event Type  malfunction  

Event Description

Patient called to report product issues she experienced with her trulicity injector pen.Patient stated that she's been using the device for years and has never had a problem before.Yesterday, the patient said she was about to give her weekly dose, pulled the cap off and put the injector to her skin and pushed the button but nothing happened.She said the device didn't engage and did not deliver her medication.Patient stated this exact problem then happened with two more injector pens from the same box, so 3 defective pens in total.Patient said she needs a replacement box and will be contacting her pharmacy to help her.

• Brand Name: TRULICITY INJECTOR PEN (BOX OF 4)
• Type of Device: INJECTOR, PEN
• Manufacturer (Section D): ELI LILLY AND COMPANY, PHARMACEUTICAL DELIVERY SYSTEMS
• MDR Report Key: 14566167
• MDR Text Key: 293176021
• Report Number: MW5110016
• Device Sequence Number: 2
• Product Code: NSC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/31/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Female