BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 23097986 · Received September 19, 2025

    Report

    Report Number
    3004464228-2025-42981
    Event Type
    Injury
    Date Received
    September 19, 2025
    Date of Event
    September 12, 2025
    Report Date
    September 19, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000548
    PMA / PMN Number
    K231826
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE DAMAGED 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. 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: G7 *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 LEVELS REACHED 350 MG/DL WHILE WEARING THE POD FOR APPROXIMATELY 26 HOURS. WHEN REMOVED FROM THE INFUSION SITE, THE CANNULA WAS BROKEN AND HALF OF THE CANNULA WAS STUCK INSIDE OF THE INSERTION SITE (ABDOMEN). THE PATIENT WORKS AT THE (B)(6) HOSPITAL AND WENT TO THE EMERGENCY ROOM. THE REST OF THE CANNULA WAS NOT REMOVED FROM THE PATIENT'S BODY AND THEY ARE WAITING FOR THE CANNULA TO GROW OUT ON IT'S OWN. PATIENT CLAIMED "THE BODY NORMALLY REJECTS SUCH THINGS AND THEY MIGHT NOT TAKE IT OUT THEMSELVES." PATIENT APPLIED JOD OINTMENT FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1970298 OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM AUTOMATED INSULIN DELIVERY SYSTEM QFG INSULET CORPORATION PT-001446 PH1K11062451 20385083000548

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female Required Intervention