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

Device Problem Defective Device (2588)

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

Event Date 02/27/2023

Event Type  Injury  

Event Description

Omnipod 5 controller software failure rendering pump uncontrollable.Second controller failure in three months.Reference reports: mw5115395 and mw5115396.

• Brand Name: OMNIPOD 5 PDM CONTROLLER
• Type of Device: INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER
• Manufacturer (Section D): INSULET CORPORATION
• MDR Report Key: 16477744
• MDR Text Key: 310732135
• Report Number: MW5115397
• 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: Unknown
• Type of Report: Initial
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 9 YR
• Patient Sex: Female
• Patient Weight: 34 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White