BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 CONTROLLER

    MDR report key: 15477023 · Received September 24, 2022

    Report

    Report Number
    3004464228-2022-17737
    Event Type
    Malfunction
    Date Received
    September 24, 2022
    Date of Event
    July 28, 2022
    Report Date
    July 28, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000022
    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 DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED CONTROLLER MALFUNCTION. 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.

    Additional Manufacturer Narrative · 0

    CORRECTION TO THESE FIELDS BELOW. D1 - BRAND NAME TO OMNIPOD 5 CONTROLLER D2A - COMMON DEVICE NAME TO ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP D2B ¿ PROCODE TO QFG D4 - MODEL NO FROM PT-000408 TO PT-000409 D4 - UNIQUE IDENTIFIER (UDI) # TO (B)(4). D4 - SERIAL NO TO (B)(6) D4 - CATALOG NO SKT-H001-G-X9 H4 - DEVICE MFG DATE.

    Additional Manufacturer Narrative · 0

    CORRECTION TO G(5): PMA/510(K) # CHANGED FROM UNAVAILABLE TO K203768.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS CONTROLLER WOULD NOT CHARGE AND THAT IT OVERHEATED WHILE IT WAS PLUGGED. THIS IN TURN PRODUCED A BURNING SMELL. THE REPORTER STATED THAT THE CHARGING SYMBOL WAS NOT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588157 OMNIPOD 5 CONTROLLER ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000409 H000453 10385083000022

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Female