BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 POD

    MDR report key: 21936250 · Received April 30, 2025

    Report

    Report Number
    3004464228-2025-18739
    Event Type
    Malfunction
    Date Received
    April 30, 2025
    Date of Event
    April 23, 2025
    Report Date
    April 30, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000432
    PMA / PMN Number
    K231826
    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. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM 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. CLOUD - LOCKED DOWN/SMARTPHONE. DATA NOT AVAILABLE. CLOUD - OMNIPOD 5 SOFTWARE APP VERSION. DATA NOT AVAILABLE. CLOUD - SMARTPHONE OPERATING SYSTEM. DATA NOT AVAILABLE. CLOUD - SMARTPHONE HARDWARE. DATA NOT AVAILABLE. CLOUD - CGM SENSOR TYPE. DATA NOT AVAILABLE. *PLEASE NOTE, THAT SECTION D IS CAPTURING THE DEVICE IDENTIFIERS AS REPORTED BY THE COMPLAINANT. THIS MAY NOT ALIGN TO THE DEVICE CONFIGURATION REPORTED IN H11, AS THIS DATA IS PULLED FROM OUR CLOUD BASED ON THE REPORTED DATE OF EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE OVER 13.9 MMOL/L (250.2 MG/DL) WHILE WEARING THE POD BETWEEN 37 AND 48 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (ABDOMEN) WHILE CLIMBING AT THE PLAYGROUND IN SCHOOL, CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241341 OMNIPOD 5 POD AUTOMATED INSULIN DELIVERY SYSTEM QFG INSULET CORPORATION PT-001443 PH1K10252441 20385083000432

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Female