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

Model Number 18239

Device Problems Battery Problem (2885); Intermittent Communication Failure (4038)

Patient Problem Diabetic Ketoacidosis (2364)

Event Date 04/02/2023

Event Type  malfunction  

Manufacturer Narrative

According to the complainant the device will not be returned for investigation.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 Description

It was reported that patient was hospitalized with diabetic ketoacidosis (dka).The omnipod personal diabetes manger (pdm) lost communication and the battery was not holding a charge.Despite good faith attempts to obtain further details, no additional information was provided.

• 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: 16690563
• MDR Text Key: 312803847
• Report Number: 3004464228-2023-09066
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 10385082000009
• UDI-Public: (01)10385082000009
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 18239
• Device Catalogue Number: USA1-D001-MG-USA1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female