BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 22993257 · Received September 8, 2025

    Report

    Report Number
    3004464228-2025-40371
    Event Type
    Malfunction
    Date Received
    September 8, 2025
    Date of Event
    August 10, 2025
    Report Date
    September 8, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000548
    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. LOT RELEASE RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. WE ARE UNABLE TO CONFIRM OR DETERMINE THE ROOT CAUSE OF THE REPORTED DISLODGED CANNULA. LOCKED DOWN SMARTPHONE: LOCKDOWN OMNIPOD SOFTWARE APP VERSION: 3.1.2-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 THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO GREATER THAN 250 MG/DL WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (LEG), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW PPOD WAS APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2066452 OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM AUTOMATED INSULIN DELIVERY SYSTEM QFG INSULET CORPORATION PT-001446 PH1K01082531 20385083000548

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male