BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 CONTROLLER

    MDR report key: 15697740 · Received October 31, 2022

    Report

    Report Number
    3004464228-2022-20295
    Event Type
    Malfunction
    Date Received
    October 31, 2022
    Date of Event
    October 15, 2022
    Report Date
    October 15, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    PMA / PMN Number
    K203768
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE THERMAL EVENT OF MELTING ON THE CONTROLLER. 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 CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.

    Additional Manufacturer Narrative · 0

    CORRECTION TO D(4): SEQUENCE NUMBER CHANGED FROM UNAVAILABLE TO 01020000-000040220. MODEL NO CHANGED FROM PT-000408 TO PT-000409. CATALOG NO CHANGED FROM UNAVAILABLE TO SKT-H001-G-X9. UNIQUE IDENTIFIER (UDI) # CHANGED TO (B)(4). CORRECTION TO G(5): PMA/510(K) # CHANGED FROM UNAVAILABLE TO K203768.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT THE CONTROLLERS CHARGING CORD AND PORT WAS MELTED WHEN IT WAS PLUGGED IN. THE FIRST CORD AND CONTROLLER WAS REPLACED BY THE PHARMACY. IT WAS REPORTED THAT THE PATIENTS BLOOD GLUCOSE LEVELS WAS AT 131 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2912452 OMNIPOD 5 CONTROLLER ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000409 H000465

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male