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

Model Number 18239

Device Problem Temperature Problem (3022)

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

Event Date 04/22/2022

Event Type  malfunction  

Manufacturer Narrative

In the case description, the user reports the pdm began to get extremely hot while not in use.A battery was returned with the device.Initially, the device did not power on using the returned battery.The device was allowed to charge with the returned battery, and the pdm powered on and booted up with no issues.Inspection of the pdm alarm history did not show any alarms on or around the date of occurrence.Both the log and ibf files were able to be downloaded.Inspection of the log files did not find any issues regarding an extremely hot temperature.The log files show the device was operating at an expected temperature, and no drastic changes in temperature were observed.Inspection of the battery and battery compartment did not show any damages or defects that would indicate the battery reached a very high temperature.No evidence was found that would indicate the device was operating at a higher than expected temperature.The pdm successfully paired with an unused pod and delivered a maximum bolus of 15 units.The pdm did not heat up during or after the completion of the bolus.The pdm was found to operate at an expected temperature during investigation.

Event Description

It was reported that the controller was extremely hot and burned through the device cover.The patient's fingers and clothing were burned as a result of this malfunction, but no medical attention was sought.

• 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: 15477353
• MDR Text Key: 305699778
• Report Number: 3004464228-2022-17733
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 10385082000009
• UDI-Public: (01)10385082000009(11)220301(10)L000417
• 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: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• 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
• Device Lot Number: L000417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2022
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female