BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 23479189 · Received November 5, 2025

    Report

    Report Number
    3004464228-2025-54033
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 21, 2025
    Report Date
    November 14, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000138
    PMA / PMN Number
    K231826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. 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 CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE. WE ARE UNABLE TO CONFIRM OR DETERMINE THE ROOT CAUSE OF THE BLOCKED CANNULA. LOCKED DOWN SMARTPHONE: LOCKDOWN OMNIPOD SOFTWARE APP VERSION: 3.1.5-P001 OPERATING SYSTEM: N5004L-AM-Q-MV01602-06-01.06 HARDWARE: N5004L CGM SENSOR TYPE: L2+. *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.

    Additional Manufacturer Narrative · 0

    UPDATED D4 PRODUCT NO FROM PT-001443 TO PT-001446.

    Additional Manufacturer Narrative · 0

    UPDATED THE EMDR-298173 REPORT THAT THE PRODUCT NO HAS BEEN CHANGED FROM PT-001446 TO PT-001443.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 24 MMOL/L (432 MG/DL) WHILE WEARING THE POD BETWEEN 37 AND 48 HOURS. WHEN REMOVED FROM THE INFUSION SITE ON THE SKIN, THE POD'S CANNULA WAS FOUND CLOGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2648567 OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-001443 PH1K11112441 10385083000138

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male