BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 CONTROLLER

    MDR report key: 16265428 · Received January 30, 2023

    Report

    Report Number
    3004464228-2023-02755
    Event Type
    Malfunction
    Date Received
    January 30, 2023
    Date of Event
    January 9, 2023
    Report Date
    January 9, 2023
    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

    THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED THE REPORTED THERMAL EVENT. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    IN THE CASE DESCRIPTION, THE USER MENTIONED THE CONTROLLER PRODUCING A BURNING ELECTRICAL SMELL WHILE CHARGING AND THE CHARGING CABLE BEING STUCK IN THE CHARGING PORT. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND NO DAMAGES THAT WOULD INDICATE THERMAL EXPOSURE. NO DAMAGES WERE OBSERVED IN OR AROUND THE CHARGING PORT OF THE CONTROLLER. THE CHARGING CABLE AND CHARGING ADAPTER WERE NOT RETURNED WITH THE CONTROLLER. NO EVIDENCE OF THE CHARGING CABLE BEING STUCK IN THE CHARGING PORT WAS OBSERVED. INSPECTION OF THE ANDROID LOG FILES DOWNLOADED FROM THE DEVICE FOUND NO EVIDENCE OF THE DEVICE GETTING HOT OR OVERHEATING. THE LOG FILES SHOWED THAT THE BATTERY TEMPERATURE DID NOT EXCEED THE UPPER LIMIT OF 40 DEGREES C. THE CONTROLLER WAS PLUGGED IN AND ALLOWED TO CHARGE IN AN ATTEMPT TO REPLICATE THE BURNING SMELL. THE CONTROLLER WAS ALLOWED TO CHARGE FOR 1 HOUR AND NO BURNING SMELLS WERE PRODUCED BY THE CONTROLLER DURING THIS TIME. NO ABNORMAL HEAT WAS FELT ON THE CONTROLLER DURING CHARGING AND THE CHARGING CABLE DID NOT GET STUCK IN THE CHARGING PORT. NO EVIDENCE OF THE REPORTED THERMAL EVENT WAS FOUND. THE SYSTEM WAS FOUND TO FUNCTION AS INTENDED. CORRECTION TO D(4): LOT NUMBER CHANGED FROM UNAVAILABLE TO H000489. SEQUENCE NUMBER CHANGED FROM UNAVAILABLE TO (B)(4). UNIQUE IDENTIFIER (UDI) # CHANGED TO (B)(4). CORRECTION TO H(4): DEVICE MFG DATE CHANGED FROM UNAVAILABLE TO 11/7/2022.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT THE OMNIPOD DIABETES MANAGER (PDM) GOT HOT WHILE CHARGING AND SHE COULD SMELL AN ELECTRICAL BURNING SMELL. THE PATIENT ALSO STATES THAT THE CHARGING CABLE APPEARS TO BE STUCK INSIDE THE CONTROLLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079 OMNIPOD 5 CONTROLLER ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000409 10385083000022

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Female