BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 POD

    MDR report key: 22488489 · Received July 12, 2025

    Report

    Report Number
    3004464228-2025-30821
    Event Type
    Malfunction
    Date Received
    July 12, 2025
    Date of Event
    June 20, 2025
    Report Date
    July 12, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000213
    PMA / PMN Number
    K203768
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE HAS BEEN DISCARDED AND WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS. LOCKED DOWN SMARTPHONE: PHONE_CONTROL_IOS. OMNIPOD SOFTWARE APP VERSION: 2.0.2. OPERATING SYSTEM: 18.4. HARDWARE: IPHONE16.1. CGM SENSOR TYPE: G6. PLEASE NOTE, THE DEVICE IDENTIFIERS ARE CAPTURED AS REPORTED BY THE COMPLAINANT AND MAY NOT ALIGN WITH THE DEVICE CONFIGURATION REPORTED IN THIS SECTION AS THIS DATA IS PULLED FROM OUR CLOUD BASED ON THE REPORTED DATE OF EVENT. THE LOT DETAILS PROVIDED SHOW THAT THE PATIENT WAS USING AN EXPIRED POD. AS PER OMNIPOD®5 AUTOMATED INSULIN DELIVERY SYSTEM - USER GUIDE(MODEL: PDM-H001-G-XX PT-000369-AW REV 009 08/22, 5 ACTIVATING AND CHANGING YOUR POD / PAGE 95) CAUTION: DO NOT USE A POD IF THE STERILE PACKAGING IS OPEN OR DAMAGED, THE POD HAS BEEN DROPPED AFTER REMOVAL FROM THE PACKAGE, OR THE POD IS EXPIRED AS THE POD MAY NOT WORK PROPERLY AND INCREASE YOUR RISK OF INFECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 270 MG/DL WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED IN THE INFUSION SITE. INFORMATION ON TREATMENT WAS NOT PROVIDED, AND THE POD HAS BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805808 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000536 PH1U10312221 10385083000213

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female