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

Model Number 19191

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Hyperglycemia (1905)

Event Date 12/29/2022

Event Type  malfunction  

Event Description

It was reported the patient's blood glucose rose to 350 mg/dl.The patient reported bleeding from the insertion site after wearing the pod for a couple of hours.As treatment, a new pod was applied.

Manufacturer Narrative

The pod was received with no evidence of blood on the device.Investigation results found no evidence of any damage or manufacturing deficiencies that would cause bleeding, bruising, or swelling at the infusion site.The exact cause of the reported swelling could not be determined.The device was received with the soft cannula deployed.Corrosion was observed on the pcb assembly, all three batteries, and the catch beam.Due to the corrosion, the bottom and middle battery voltages were measured to be lower than expected.Fluid path testing found a tear on the unexposed portion of the soft cannula which resulted in an internal leak.This leak prevented the proper delivery of insulin.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 confirming the blue soft cannula is inspected for any damage.

• 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: 16708129
• MDR Text Key: 312974124
• Report Number: 3004464228-2023-09210
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120033
• UDI-Public: (01)20385081120033(11)211028(17)230428(10)L50286
• 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: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/28/2023
• Device Model Number: 19191
• Device Catalogue Number: ZXP425
• Device Lot Number: L50286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2023
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Sex: Male