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

Model Number	18900-5A
Medical Device Problem Code	Reset Problem (3019)
Health Effect - Clinical Codes	Hyperglycemia (1905); Nausea (1970); Vomiting (2144)
Date of Event	06/14/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 454mg/dl.The patient was nauseous and vomiting.For treatment, the patient was given zofran, fluids and insulin.The patient was still in the hospital.
Additional Manufacturer Narrative
In the case description, the user mentioned receiving a pdm alarm.After inserting batteries, the device turned on and booted to the omnipod splash screen.The pdm then flashed a white screen and then showed the omnipod splash screen again.The main menu of the pdm was unable to be accessed as the omnipod splash screen continued to loop, indicating a processor boot loader failure.All attempts to restart the device were unsuccessful in clearing the splash screen.The.Ibf data from the pdm was unable to be downloaded and the pdm records were unable to be viewed as the pdm was unable to reach the main menu.Without the data it could not be conclusively determined if the pdm generated any alarms during operation.Inspection of the pdm found red on the fluid ingress indicator, indicating that fluid made contact with the battery compartment of the device.Inspection of the pcb assemblies found corrosion on the mother pcb assembly.It could not be conclusively determined if this corrosion contributed to the reported event or the observed boot loader failure.

• Brand Name: OMNIPOD INSULIN MANAGEMENT SYSTEM
• Common Device Name: 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: 17191967
• Report Number: 3004464228-2023-15945
• Device Sequence Number: 5642756
• Product Code: LZG
• UDI-Device Identifier: 10385081120012
• UDI-Public: (01)10385081120012(11)190816(10)L61152
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K211575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 18900-5A
• Device Catalogue Number: PDM-UST400
• Device Lot Number: L61152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female