MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM CONTROLLER; INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER

Device Problems Communication or Transmission Problem (2896); Inappropriate or Unexpected Reset (2959)

Patient Problem Hyperglycemia (1905)

Event Date 08/18/2022

Event Type  malfunction  

Event Description

On new omnipod 5 insulin pump for 2.5 months now.Got an error message on the controller in the middle of the night during a bolus to correct a blood sugar of about 175: omnipod 5 memory corruption.It required a hard reset of the omnipod controller that erased all of my history and settings to manage insulin delivery.The insulin pump (pod) i was wearing also had to be discarded because it ceased communication with the controller.As a result, it took over an hour to reset the controller and put all of the settings back in, not to mention having to prematurely replace my insulin pod.This has set me back 2.5 months because the system 'learns' from your use.Additionally, i'm out 1 pod + 3 days of insulin since the pod i was wearing had to be replaced with a new one filled with new insulin.Hopefully this is a rare event & will not happen again; if it does, i will not continue to use this device.Fda safety report id# (b)(4).

• Brand Name: OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM CONTROLLER
• Type of Device: INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER
• Manufacturer (Section D): INSULET CORPORATION
• MDR Report Key: 15276265
• MDR Text Key: 298506616
• Report Number: MW5111650
• Device Sequence Number: 2
• Product Code: QJI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/18/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: DEXCOM G6 CONTINUOUS BLOOD GLUCOSE MONITOR ; INSULIN; LEVOTHYROXINE
• Patient Age: 52 YR
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White