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

Model Number 19191

Device Problem Difficult to Insert (1316)

Patient Problems Hyperglycemia (1905); Pain (1994); Swelling (2091)

Event Date 11/15/2020

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.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.

Event Description

It was reported that the patient's blood glucose level rose to around 360 mg/dl while wearing the pod less than an hour.Bleeding, pain, and swelling at the infusion site were also reported.The patient reported being unsure if the cannula was properly seated in the infusion site (arm).As treatment, the pod was removed and a new pod was applied.

• 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: jordan biswurm ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 10920890
• MDR Text Key: 218730391
• Report Number: 3004464228-2020-18555
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120033
• UDI-Public: (01)20385081120033(11)190630(17)201230(10)L44953
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/30/2020
• Device Model Number: 19191
• Device Catalogue Number: ZXP425
• Device Lot Number: L44953
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 11 YR