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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY, PHARMACEUTICAL DELIVERY SYSTEMS TRULICITY PEN; INJECTOR, PEN
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ELI LILLY AND COMPANY, PHARMACEUTICAL DELIVERY SYSTEMS TRULICITY PEN; INJECTOR, PEN Back to Search Results
Lot Number D283457
Device Problems Failure to Infuse (2340); Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/27/2021
Event Type  malfunction  
Event Description
Patient reports that on the morning of (b)(6) 2021, he removed the rubber stopper attached to the end of the trulicity pen, swab his skin and put the larger tube with the needle attached onto his skin to administer the medication.Patient states he pressed the button to dispense medication but did not feel the sensation of the needle puncture his skin and did not see a hole or blood at the site.Patient reports that he examined the device and noted that the needle injected into the 1 inch base that had not come out when he initially removed the stopper.Patient notes no harm but states concern with missed medication dose.Patient reports contacting the manufacturer who alleged he wait about 3 days before applying another dose to see if the medication had dispensed and to send the device for investigation.Patient stated that due to the lack of evidence of puncture and seeing liquid still in the vial, that he used another pen to deliver dosage without complication.
 
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Brand Name
TRULICITY PEN
Type of Device
INJECTOR, PEN
Manufacturer (Section D)
ELI LILLY AND COMPANY, PHARMACEUTICAL DELIVERY SYSTEMS
lilly corporate center , drop code 1084
indianapolis IN 46285
MDR Report Key11921971
MDR Text Key254058894
Report NumberMW5101660
Device Sequence Number1
Product Code NSC
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/01/2022
Device Lot NumberD283457
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age60 YR
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