BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 POD

    MDR report key: 15276765 · Received August 23, 2022

    Report

    Report Number
    3004464228-2022-15197
    Event Type
    Malfunction
    Date Received
    August 23, 2022
    Date of Event
    July 8, 2022
    Report Date
    August 16, 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 BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. 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 D1 - BRAND NAME CHANGED FROM UNAVAILABLE TO OMNIPOD 5 POD. 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): MODEL NO CHANGED FROM PT-000536 TO PT-000435. CATALOG NO CHANGED FROM UNAVAILABLE TO POD-BLE-H1-520. 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 THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED UP TO 430 MG/DL WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. PATIENT REPORTED THE POD WAS LEAKING DURING WEAR. WHEN REMOVED FROM THE INFUSION SITE (LEG), THE POD'S CANNULA WAS FOUND BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2404601 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000435 PP1K03022231

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male