MAUDE Adverse Event Report: ELI LILLY AND COMPANY, PHARMECEUTICAL DELIVERY SYS SYRINGE, PISTON

Device Problem Defective Component (2292)

Patient Problems Hypoglycemia (1912); Coma (2417); Convulsion/Seizure (4406)

Event Date 12/23/2009

Event Type  Injury  

Event Description

The customer reported that she was using a humalog insulin pen developed by lilly that was defective and caused her to task too much insulin.She reported a consequent hypoglycemic event in which she went into a coma and that she had a seizure while in the coma.The customer's daughter found her and called an ambulance.Customer was treated at a hospital with an iv.Customer does not know what was in the iv.N/a.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SYRINGE, PISTON
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): ELI LILLY AND COMPANY, PHARMECEUTICAL DELIVERY SYS
• MDR Report Key: 17537631
• MDR Text Key: 321046256
• Report Number: MW5144486
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1