BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 POD

    MDR report key: 22741647 · Received August 7, 2025

    Report

    Report Number
    3004464228-2025-35327
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    July 9, 2025
    Report Date
    August 7, 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 WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED 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 CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE. 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. LOCKED DOWN SMARTPHONE: LOCKDOWN. OMNIPOD SOFTWARE APP VERSION: 3.1.1. OPERATING SYSTEM: N5004L-AM-Q-MV01602-06-01.06. HARDWARE: N5004L. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 380 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. UPON REALIZATION OF HIGH BGS, THE POD WAS REMOVED FROM THE INFUSION SITE (ARM), AND IT WAS OBSERVED THAT THE POD'S CANNULA WAS BENT. INFORMATION ON TREATMENT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2006019 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000536 PH1K08122211 10385083000213

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Unknown