MAUDE Adverse Event Report: INSULET CORPORATION INSULET OMNIPOD 5 G6 SYSTEM POD (GEN 5); INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER

Lot Number PH1U11162221

Device Problem Defective Device (2588)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Customer reports a defective batch of omnipods, due to this defective product the customer reports that they were hospitalized last week with dka(diabetic ketoacidosis).They believe that the pods are not delivering insulin like they should and suspects that the cannula is not reaching the insulin.

• Brand Name: INSULET OMNIPOD 5 G6 SYSTEM POD (GEN 5)
• Type of Device: INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER
• Manufacturer (Section D): INSULET CORPORATION
• MDR Report Key: 17185680
• MDR Text Key: 317743692
• Report Number: MW5118697
• Device Sequence Number: 1
• Product Code: QJI
• 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: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: PH1U11162221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization