BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 CONTROLLER

    MDR report key: 15636045 · Received October 19, 2022

    Report

    Report Number
    3004464228-2022-19605
    Event Type
    Malfunction
    Date Received
    October 19, 2022
    Date of Event
    September 23, 2022
    Report Date
    September 25, 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 WAS RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED THERMAL EVENT OR DETERMINE ITS ROOT CAUSE UNTIL AN INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    CORRECTION TO D1 - BRAND NAME CHANGED FROM UNAVAILABLE TO OMNIPOD 5 CONTROLLER. D2A - COMMON DEVICE NAME CHANGED FROM UNAVAILABLE TO ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP. D2B - PROCODE CHANGED FROM UNAVAILABLE TO QFG. CORRECTION TO D(4): SEQUENCE NUMBER CHANGED FROM UNAVAILABLE TO (B)(6). 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. CORRECTION TO H(4): DEVICE MFG DATE CHANGED FROM UNAVAILABLE TO 6/16/2022.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT REPORTED THERMAL ISSUE IS CURRENTLY UNDER THE REFERENCED CAPA INVESTIGATION, AND HAS BEEN VERIFIED BY THE RETURNED DEVICE. NO FURTHER POST MARKET LAB INVESTIGATION EVALUATION IS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT STARTED SMELLING SOMETHING BURNING COMING FROM THE CONTROLLER, AND NOTICED THE CHARGING PORT WAS MELTING. THE CHARGER CABLE WAS SAID TO BE BROKEN. THE DEVICE IN QUESTION HAS SINCE BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2743015 OMNIPOD 5 CONTROLLER ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000409 H000464

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female