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

Model Number 19191

Device Problems Difficult to Insert (1316); Material Twisted/Bent (2981)

Patient Problems Dehydration (1807); Headache (1880); Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Urinary Frequency (2275); Diabetic Ketoacidosis (2364); Abdominal Cramps (2543)

Event Date 12/12/2022

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.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 emergency room (er) and was diagnosed with diabetic ketoacidosis.The patient's blood glucose (bg) values reached 412 mg/dl.The patient had increased thirst, frequent urination, nausea, vomiting, stomach pains and headache.For treatment, the patient was given insulin and bloodwork.The patient reported being unsure if the cannula was properly seated and bent, while wearing the pod longer than 48 hours on the arm.The patient was discharged after 3 days.

• 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: 16039849
• MDR Text Key: 306043707
• Report Number: 3004464228-2022-24396
• Device Sequence Number: 1
• Product Code: LZG
• 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
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/15/2023
• Device Model Number: 19191
• Device Catalogue Number: ZXP425
• Device Lot Number: L71352
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female