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

Model Number 18320

Device Problems Fluid/Blood Leak (1250); Material Twisted/Bent (2981); Unintended Movement (3026)

Patient Problem Hyperglycemia (1905)

Event Date 04/15/2023

Event Type  malfunction  

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 confirm the bent cannula or to determine if it could have contributed to the reported hyperglycemia.It was reported, that the cannula had dislodged from the infusion site.This condition could interrupt insulin delivery and contribute to hyperglycemia.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.

Event Description

It was reported, the patient's blood glucose level rose to over 400 mg/dl, while wearing the pod between 5 and 24 hours.The patient reporting insulin leaking.When removed from the infusion site (back), the pod's cannula was found bent and cannula had dislodged.As treatment, a new pod was placed.

Manufacturer Narrative

The received device had the cannula assembly fully deployed.Inspection of the soft cannula did not find it bent, kinked, or damaged.The download data does not contain time outs, drive stalls or alarm.The length of soft cannula was observed to be within specification.Fluid path test was conducted.Upon manual rotation of the ratchet gear, fluid was found to exit the fluid path as intended.No signs of leakage were found along the fluid path during the leak test.Investigation found no defects or manufacturing deficiencies that would contribute to a dislodging of the cannula.The exact cause of the reported dislodging could not be determined.

• 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: 16824474
• MDR Text Key: 314103797
• Report Number: 3004464228-2023-10820
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385082000020
• UDI-Public: (01)20385082000020(11)220318(17)230918(10)PD1K03182231
• 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,Followup
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/18/2023
• Device Model Number: 18320
• Device Catalogue Number: BLE-I1-529
• Device Lot Number: PD1K03182231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Sex: Female