BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 PODS

    MDR report key: 21842571 · Received April 15, 2025

    Report

    Report Number
    3004464228-2025-15990
    Event Type
    Malfunction
    Date Received
    April 15, 2025
    Date of Event
    March 23, 2025
    Report Date
    April 15, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    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. *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. LOCKED DOWN SMARTPHONE: PHONE_CONTROL_ANDROID OMNIPOD SOFTWARE APP VERSION: 3.1.1 SMARTPHONE OPERATING SYSTEM: TP1A.220624. 014.G781VSQSIHXL2 SMARTPHONE HARDWARE: SM-G781V CGM SENSOR TYPE: G6.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO OVER 250 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. IN ADDITION THE PATIENT REPORTS WHILE SLEEPING THE PODS ADHESIVE HAD SEPARATED FROM THE POD INFUSION SITE (LEG), CAUSING THE CANNULA TO BECOME DISLODGED. AS TREATMENT, THE PATIENT APPLIED A NEW POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109335 OMNIPOD 5 PODS OMNIPOD 5 PODS QFG INSULET CORPORATION PT-001662 PH1U03262431

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female