BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 PODS

    MDR report key: 22680255 · Received July 31, 2025

    Report

    Report Number
    3004464228-2025-34304
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Date of Event
    July 2, 2025
    Report Date
    September 7, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED WITH THE CANNULA ASSEMBLY FULLY DEPLOYED. NO DAMAGES OR DEFECTS WERE OBSERVED THAT WOULD RESULT IN THE SOFT CANNULA DISLODGING. THE CAUSE OF THE REPORTED DISLODGING EVENT COULD NOT BE CONCLUSIVELY DETERMINED. INVESTIGATION OF THE BOTTOM HOUSING INDICATES THAT THE ADHESIVE WAS PROPERLY WELDED TO THE DEVICE AND NO DAMAGES OR DEFECTS WERE OBSERVED THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. THE CAUSE OF THE REPORTED ADHESIVE ISSUE COULD NOT BE DETERMINED. INITIAL INSPECTION OF THE POD FOUND THE EXPOSED PORTION OF THE SOFT CANNULA TO BE MISSING ALTHOUGH THE SLIDE INSERT WAS FULLY VISIBLE THROUGH THE TOP HOUSING WINDOW. UPON REMOVAL OF THE HOUSING, THE CANNULA WAS OBSERVED TO BE SHORTENED MEASURING OUT TO BE 0.5860 INCHES. FLUID COULD NOT FLOW THROUGH THE COMPLETE FLUID PATH. IT COULD NOT BE DETERMINED IF THE OBSERVED CANNULA DAMAGE CONTRIBUTED TO THE REPORTED LEAKING DURING WEAR EVENT. THE EXACT TIMING AND CAUSE OF THE OBSERVED CANNULA DAMAGE COULD NOT BE DETERMINED.

    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. 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: 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 LEVEL (BG) ROSE TO 330 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE POD WAS REPORTEDLY LEAKING INSULIN AND CAUSE THE POD TO FALL OFF OF INFUSION SITE (ARM), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS APPLIED. THIS IS POD 3 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2239138 OMNIPOD 5 PODS OMNIPOD 5 PODS QFG INSULET CORPORATION PT-001662 PH1U09252411 20385083000579

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male