inforMED
MalfunctionNSC

TRULICITY INJECTOR PEN (BOX OF 4)

Received May 31, 2022 · Event occurred May 30, 2022

Report MW5110016 · MDR key 14566167

Device

Generic name

Injector, Pen

Product problems

  • Mechanical Problem
  • Failure to Deliver

Patient

64 YR · Female

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

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.