MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD DASH, PDM, PERSONAL DIABETES MANAGER; PUMP, INFUSION, INSULIN

Model Number PT-000030

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

Patient Problem Chemical Exposure (2570)

Event Date 11/08/2022

Event Type  malfunction  

Event Description

It was reported by the patient that the omnipod personal diabetes manager (pdm) was overheating.The patient also reported that the pdm was no longer holding a charge.The patient reported that the screen on the pdm was fading during event.

Manufacturer Narrative

A technical assessment of the device design identified the root cause of the thermal event to be the dash pdm charging voltage exceeding the battery specification, defined as overcharging.Field safety corrective action has been initiated by insulet corporation.The device will not be returned for investigation.

• Brand Name: OMNIPOD DASH, PDM, PERSONAL DIABETES MANAGER
• 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: 15882225
• MDR Text Key: 304500997
• Report Number: 3004464228-2022-22085
• Device Sequence Number: 1
• Product Code: LZG
• 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: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PT-000030
• Device Catalogue Number: PDM-CAN-D001-MM
• Device Lot Number: L000314
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male