BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 POD

    MDR report key: 20893856 · Received December 10, 2024

    Report

    Report Number
    3004464228-2024-49603
    Event Type
    Injury
    Date Received
    December 10, 2024
    Date of Event
    November 20, 2024
    Report Date
    January 31, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000022
    PMA / PMN Number
    K203768
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE WAS EVALUATED AND THE IN THE CASE DESCRIPTION, THE USER MENTIONED HAVING LOW BLOOD GLUCOSE (BG) LEVELS DUE TO A POD SWITCHING INTO MANUAL MODE WITH NO INPUT FROM THE USER. REVIEW OF THE ANDROID LOG FILES DOWNLOADED FROM THE RETURNED CONTROLLER FOUND NO EVIDENCE OF AN OVER DELIVERY OF INSULIN AND FOUND EVIDENCE OF INTERACTION WITH THE CONTROLLER TO SWITCH MODES FROM AUTOMATED TO MANUAL. REVIEW OF THE LOG FILES FOUND THAT, ON THE DATE OF OCCURRENCE, THE "SWITCH TO MANUAL MODE?" DIALOG BOX WAS GENERATED THREE TIMES. THE FIRST TWO INSTANCES HAD THE CANCEL BUTTON PRESSED, WHILE THE THIRD INSTANCE SHOWED THE YES BUTTON BEING PRESSED. THIS RESULTED IN THE SWITCH MODE COMMAND BEING SENT TO THE POD. THE POD THEN BEGAN DELIVERING THE USER'S MANUAL BASAL PROGRAM, AS EXPECTED. NO EVIDENCE OF THE SYSTEM SWITCHING MODES WITHOUT INPUT WAS OBSERVED IN THE LOGS. PHYSICAL TESTING OF THE CONTROLLER FOUND NO ISSUES THAT WOULD RESULT IN THE SYSTEM SWITCHING MODES WITHOUT INPUT. THE CONTROLLER WAS DETERMINED TO HAVE FUNCTIONED AS INTENDED.

    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 HOSPITALIZATION AND HYPOGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    D4: CATALOG # POD-BLE-H1-520 CHANGED TO PDM-H001-G-XX. D4: PRIMARY UDI NUMBER CHANGED FROM (B)(4) CHANGED TO (B)(4). ADDED D4: SERIAL #(B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH HYPOGLYCEMIA. THE PATIENT'S BLOOD GLUCOSE LEVELS HAD DECREASED TO 15 MG/DL WHILE WEARING THE POD. THE PATIENTS CONTROLLER WAS IN MANUAL MODE AS THEY HAD NOT BEEN RECEIVING VALUES FROM THEIR SENSOR. THE PATIENT REPORTS WHILE AT WORK THEY HAD BEEN VOMITING AND WAS HAVING DIFFICULTY MOVING. THE PATIENTS COWORKERS CONTACTED EMERGENCY MEDICAL SERVICES (EMS). UPON ARRIVAL OF EMS THE PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS AND TAKEN TO THE HOSPITAL. THE PATIENT WAS AT THE HOSPITAL FOR 40 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2476753 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000409 10385083000022

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Unknown Hospitalization