BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 PODS

    MDR report key: 21081921 · Received January 6, 2025

    Report

    Report Number
    3004464228-2025-00788
    Event Type
    Malfunction
    Date Received
    January 6, 2025
    Date of Event
    October 24, 2024
    Report Date
    January 6, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000579
    PMA / PMN Number
    K231826
    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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO >250 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN) AFTER BATHING, THE POD'S CANNULA WAS FOUND TO BE DISLOD GED. AS TREATMENT A NEW POD WAS APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962571 OMNIPOD 5 PODS OMNIPOD 5 PODS QFG INSULET CORPORATION PT-001662 PH1U05172431 20385083000579

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Female