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

Model Number 14000

Device Problem Material Twisted/Bent (2981)

Patient Problems Hyperglycemia (1905); Dizziness (2194); Diabetic Ketoacidosis (2364); Cognitive Changes (2551)

Event Date 12/18/2022

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 had been hospitalized with diabetic ketoacidosis (dka).The patient's blood glucose levels read high (>500 mg/dl) while wearing the pod between 4 and 24 hours.Symptoms reported include hyperglycemia, dizziness, weakness and confusion.In addition the patient was unable to walk.Once at the hospital the patients pod was removed and the cannula had been found to be bent.The patient applied a new pod and administered a bolus of 20 units of insulin.The patient had blood work performed and the patients blood glucose level was monitored.The patient was give intravenous fluids as well as insulin.The patient was prescribed ibuprofen (100 mg) and ondansetron (4 mg) to be taken once every 12 hours as needed for nausea.As a result of this event the patient had manual insulin administered the following week.The patient was discharged from the hospital after 2 days.

Manufacturer Narrative

The received device had the cannula assembly fully deployed.Inspection of the cannula assembly did not find it bent, kinked, or damaged.The investigation found no evidence of any damage or manufacturing deficiencies that would result in the device failing to deliver insulin.

• 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: 16246714
• MDR Text Key: 308170611
• Report Number: 3004464228-2023-02240
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120002
• UDI-Public: (01)20385081120002(11)220305(17)230905(10)L72391
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/05/2023
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Device Lot Number: L72391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 9 YR
• Patient Sex: Female