MAUDE Adverse Event Report: ELI LILLY AND COMPANY INSULIN PEN; SYRINGE PISTON

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2017

Event Type  Injury  

Event Description

Reporter alleges she is having big bubbles in the insulin pen and she is concerned air can enter her blood stream and kill her.Reporter added she has been a diabetic for 63 years and is very familiar with the use of syringes.She is unable to get the air bubbles out of the pen and is very unhappy with the insulin pen.

• Brand Name: INSULIN PEN
• Type of Device: SYRINGE PISTON
• Manufacturer (Section D): ELI LILLY AND COMPANY
• MDR Report Key: 7295807
• MDR Text Key: 101087277
• Report Number: MW5075486
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Other Device ID Number: NDC0002-7715-01
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 64