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

Model Number 18025

Device Problem Difficult to Insert (1316)

Patient Problems Dehydration (1807); Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Urinary Frequency (2275); Diabetic Ketoacidosis (2364)

Event Date 10/10/2022

Event Type  Injury  

Manufacturer Narrative

The device has not been returned/received to date.If the device is received, a supplemental report will be submitted with the investigation results.We are unable to determine if any product condition could have contributed to the reported hospitalization and diabetic ketoacidosis.It was reported the cannula was possibly not inserted correctly into the infusion site.This condition could interrupt insulin delivery and contribute to hyperglycemia.Lot release records were reviewed and the product lot met all acceptance criteria.Specifically, a pod is paired to a pdm and put through simulated use testing including communicating with the pdm, deployment, delivering fluid, occlusion detection, and freedom from hazard alarms.

Event Description

It was reported that the patient went to the hospital and was diagnosed with diabetic ketoacidosis (dka).The patient's blood glucose (bg) values reached 508 mg/dl.The patient had large ketones, dehydration, frequent urination, nausea and vomiting.For treatment, the patient was provided intravenous (iv) fluids and medication for nausea.The patient reported being unsure if the cannula was properly seated, while wearing between 36 and 48 hours on the back.The patient was discharged after 1 day.

Manufacturer Narrative

Correction to d(4): catalog no changed from unavailable to zxp425.Correction to g(5): pma/510(k) # changed from unavailable to k192659.

• Brand Name: OMNIPOD INSULIN MANAGEMENT SYSTEM
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer (Section G): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer Contact: michael spears ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 15617249
• MDR Text Key: 301856521
• Report Number: 3004464228-2022-19362
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120057
• UDI-Public: (01)20385081120057(11)211206(17)230606(10)L72355
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/06/2023
• Device Model Number: 18025
• Device Catalogue Number: ZXP425
• Device Lot Number: L72355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 6 YR
• Patient Sex: Female