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

Model Number PT-000011

Device Problems Overheating of Device (1437); Failure to Power Up (1476); Battery Problem (2885)

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

Event Date 04/18/2023

Event Type  malfunction  

Manufacturer Narrative

According to the complainant the device will not be returned for investigation.We are unable to confirm the reported the reported thermal event.No lot release records were reviewed, as the product lot number was not provided.

Event Description

It was reported by the patient that the omnipod personal diabetes manager (pdm) got extremely hot while it was in his pocket.The patient stated that he was trying to deliver a bolus and noticed that the pdm was off.The patient plugged the pdm into the charger but the pdm still will not turn on.

• 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: 16776110
• MDR Text Key: 313651948
• Report Number: 3004464228-2023-10130
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 10385082000146
• UDI-Public: (01)10385082000146
• 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: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PT-000011
• Device Catalogue Number: INT1-D001-MG
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/18/2023
• 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 Age: 31 YR
• Patient Sex: Male