MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD INSULIN PUMP; PUMP, INFUSION, INSULIN

Model Number 14000

Device Problem Unintended Movement (3026)

Patient Problems Vomiting (2144); Diabetic Ketoacidosis (2364)

Event Date 12/01/2013

Event Type  Injury  

Event Description

An insulet clinical services manager reported that the pt was at school when he felt like he was being poked at the infusion site and upon inspection he noticed the cannula was not inserted into the infusion site.He did not tell the school nurse or call his mother and he continued to wear the pod.When he returned home from school his blood glucose was extremely high so his parent gave him multiple bolus correction (exact bg level and insulin dosage was not provided) with no improvement to his bg levels.He was vomiting so they checked for ketones and they were present.The parent called his physician who advises them to take him to the emergency room.At the er he was diagnosed for diabetic ketoacidosis.

Manufacturer Narrative

The product was not returned for eval.We are unable to confirm any product malfunction or other product condition to have contributed to the pt's ketoacidosis and er visit.The user reported a dislodged cannula.This condition would interrupt insulin delivery and contribute to hyperglycemia if it occurred.No product lot number was reported therefore no qualification records were reviewed.

• Brand Name: OMNIPOD INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; bedford MA
• Manufacturer Contact: michael doyle ; 9 oak park dr.; bedford, MA 01730 ; 7814575000
• MDR Report Key: 3609084
• MDR Text Key: 4088932
• Report Number: 3004464228-2014-00108
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): N
• PMA/PMN Number: K122953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 10 YR