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

Model Number 18239

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425); Battery Problem (2885)

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

Event Date 04/11/2023

Event Type  malfunction  

Event Description

It was reported by the patient that the omnipod personal diabetes manager (pdm) battery would not hold charge and noticed a burning smell while charging.

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.We are unable to confirm the reported the reported thermal event.Lot release records were reviewed and the product lot met all acceptance criteria.

Manufacturer Narrative

The user reported the battery does not hold charge and a burning smell was noticed while the device was charging.A battery was returned with the device.The device powered on with no issues.No damages or defects were observed to the battery or to the battery compartment.Inspection of the charging port found no damages or defects.The device was allowed to charge during investigation and was not observed to heat up, and no burning smell was noticed.Inspection of the log files found no signs of the device overheating.The log files show the device was operating within the specifications.Inspection of the log files found no signs of power sensitivity issues.A battery life test was performed to simulate typical patient use.During the battery life test, the battery level was observed to decrease from 70% to 5% in less than 2 hours.The log files show the device was operating within the temperature specifications for the duration of the battery life test.Investigation confirms the battery is unable to hold charge for 48 hours per the design specifications, but the exact cause of the inability of the battery to hold charge could not be conclusively determined.

• 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: 16755732
• MDR Text Key: 313448611
• Report Number: 3004464228-2023-09838
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 10385082000009
• UDI-Public: (01)10385082000009(11)230223(10)L000540
• 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,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• 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: L000540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2023
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 7 YR
• Patient Sex: Female