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

Model Number 18320

Device Problem Difficult to Insert (1316)

Patient Problems Dehydration (1807); Dyspnea (1816); Hyperglycemia (1905); Vomiting (2144); Diabetic Ketoacidosis (2364)

Event Date 09/17/2022

Event Type  Injury  

Event Description

It was reported that the patient had been hospitalized with diabetic ketoacidosis (dka).The patient's blood glucose levels reached 749 mg/dl while wearing the pod between 4 and 24 hours.Symptoms reported include thirst, weakness, vomiting and difficult breathing.The patient reports being unsure if the cannula had properly inserted into the infusion site.The patient was taken by ambulance to the hospital.Once at the hospital the patient was treated with intravenous fluids as well as manual insulin shots every 2 hours.In addition the patient was given zofran every 6-8 hours.The patient was discharged from the hospital after 4 days.

Manufacturer Narrative

According to the complainant the device will not be returned for investigation.We are unable to determine if any product condition could have contributed to the reported hospitalization and diabetic ketoacidosis.In addition it was reported the cannula was possibly not inserted correctly into the infusion site.This condition could interrupt insulin delivery and contribute to hyperglycemia.No lot release records were reviewed, as the product lot number was not provided.

• Brand Name: OMNIPOD DASH 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: 16521839
• MDR Text Key: 311059561
• Report Number: 3004464228-2023-06750
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385082000020
• UDI-Public: (01)20385082000020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211575
• 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: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 18320
• Device Catalogue Number: BLE-I1-529
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2023
• Initial Date FDA Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 52 YR
• Patient Sex: Female