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

Model Number 18239

Device Problems Fluid/Blood Leak (1250); Battery Problem (2885); Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/17/2022

Event Type  malfunction  

Event Description

It was reported by the patient that the pdm was leaking from the location of the battery.It was also reported that the battery was bulging and constantly overheating.The patient described the leaking as a foam like substance.The screen did become black and unresponsive.There was nothing unusual about the outlet used to charge the pdm.

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 that the pdm battery was leaking a foam like substance.No lot release records were reviewed, as the product lot number was not 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: 15673661
• MDR Text Key: 306425432
• Report Number: 3004464228-2022-20083
• 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: 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: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 10/17/2022
• 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 Age: 36 YR
• Patient Sex: Female