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

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Omnipod 5 on immediate backorder after launch.People that need this product left with no alternatives after singing up for their contract.Fda safety report id# (b)(4).

• Brand Name: OMNIPOD 5
• Type of Device: INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER
• Manufacturer (Section D): INSULET CORPORATION
• MDR Report Key: 15249577
• MDR Text Key: 298401903
• Report Number: MW5111552
• Device Sequence Number: 1
• Product Code: QJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1