MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5 CONTROLLER (PDM); INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER

Device Problems Display or Visual Feedback Problem (1184); Material Integrity Problem (2978); Wireless Communication Problem (3283)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 04/10/2023

Event Type  Injury  

Event Description

Reporter calling to report problems controlling his blood sugars using the closed loop system of his omnipod 5 and dexcom g6.Reporter states he is having problems daily and has experienced both hyperglycemia and hypoglycemia as a result of device-related problems.On (b)(6) 2023, reporter received a "pod error" and states the controller would not communicate with the pod, as well as other pod failures when the pod is "less than 24 hours old".He also explains that his dexcom g6 gives "confusing" notifications and is not very user friendly.Reporter states he was diagnosed with type 1 diabetes at the age of three, and he is very familiar with how these devices are supposed to function.Reporter states he has contacted both insulet corporation and dexcom regarding these problems but "they do not want to fix this."reporter states that when he is physically active outdoors that the pdm (personal diabetes manager) "shuts down" and then "the pump cannot figure out what to do".Reporter expresses his frustration and wants insulet corporation and dexcom to "just fix your products".Reference reports: mw5116591, mw5116593.

• Brand Name: OMNIPOD 5 CONTROLLER (PDM)
• Type of Device: INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER
• Manufacturer (Section D): INSULET CORPORATION
• MDR Report Key: 16731889
• MDR Text Key: 313426508
• Report Number: MW5116592
• Device Sequence Number: 1
• Product Code: QJI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Life Threatening
• Patient Age: 30 YR
• Patient Sex: Male