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

Model Number PT-000011

Device Problem Failure to Power Up (1476)

Patient Problem Diabetic Ketoacidosis (2364)

Event Date 04/24/2023

Event Type  Injury  

Event Description

It was reported by the patient's doctor that the patient is currently being hospitalized with diabetic ketoacidosis (dka).The patient's blood glucose levels rose above 250 mg/dl.The personal diabetes manager (pdm) reportedly will not turn on.When the pdm is plugged into the charger, the screen remains blank and there is no charging symbol.The patient is unable to use the pdm for treatment and does not have a backup method for insulin delivery.The patient is currently being treated with an insulin infusion at the hospital.The doctor requested for a new pdm to be sent to the hospital and the patient will be discharged once the pdm is received.

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.

• 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: thom mcnamara ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 16830846
• MDR Text Key: 314159221
• Report Number: 3004464228-2023-10947
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 10385082000146
• UDI-Public: (01)10385082000146(11)221210(10)L000506
• 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: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2023

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: PT-000011
• Device Catalogue Number: INT1-D001-MG
• Device Lot Number: L000506
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/25/2023
• Initial Date FDA Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 19 YR
• Patient Sex: Female