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

Model Number 18325

Device Problems Fluid/Blood Leak (1250); Difficult to Insert (1316)

Patient Problems Hyperglycemia (1905); Itching Sensation (1943)

Event Date 04/05/2023

Event Type  malfunction  

Event Description

It was reported the patient's blood glucose level rose to 26.6 mmol/l (478.8 mg/dl) while wearing the pod between 25 and 36 hours.The patient reported the smell of leaking insulin and being unsure if the cannula was properly seated in the infusion site (abdomen).As treatment, the patient gave manual corrections using an insulin pen.

Manufacturer Narrative

According to the complainant the device will not be returned for investigation.It was reported the cannula was possibly not inserted correctly into 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 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: michael spears ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 16713739
• MDR Text Key: 313040426
• Report Number: 3004464228-2023-09321
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385082000051
• UDI-Public: (01)20385082000051(11)211129(17)230529(10)PD1U11292131
• 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: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/29/2023
• Device Model Number: 18325
• Device Catalogue Number: BLE-P1-525
• Device Lot Number: PD1U11292131
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2023
• Initial Date FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Sex: Female