BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 POD

    MDR report key: 15533479 · Received October 3, 2022

    Report

    Report Number
    3004464228-2022-18405
    Event Type
    Malfunction
    Date Received
    October 3, 2022
    Date of Event
    September 26, 2022
    Report Date
    September 26, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000114
    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 THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 400 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. WHEN REMOVED FROM THE INFUSION SITE, THE POD'S CANNULA WAS FOUND BENT. DETAILS REGARDING TREATMENT WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2929699 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000435 PP1K03022221 10385083000114

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female