BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 POD

    MDR report key: 15100270 · Received July 25, 2022

    Report

    Report Number
    3004464228-2022-12872
    Event Type
    Malfunction
    Date Received
    July 25, 2022
    Date of Event
    June 13, 2022
    Report Date
    June 13, 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

    INVESTIGATION OF THE HARD CANNULA FOUND THE FORMED NEEDLE TO BE DAMAGED, CAUSING SKIN IRRITATION AT THE INFUSION SITE. IT COULD NOT BE DETERMINED WHEN THIS DAMAGE OCCURRED. THE EXACT CAUSE OF THIS DAMAGE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    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 300 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS ON THE ABDOMEN. PATIENT REPORTED THE POD WAS LEAKING DURING WEAR. AS TREATMENT, A CORRECTION BOLUS WAS DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355204 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000435 PP1K01172211

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Female