BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 POD

    MDR report key: 15048903 · Received July 18, 2022

    Report

    Report Number
    3004464228-2022-12225
    Event Type
    Malfunction
    Date Received
    July 18, 2022
    Date of Event
    July 9, 2022
    Report Date
    July 11, 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. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED OVER 400 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. DUE TO ELEVATED BG LEVELS, PATIENT WAS UNSURE IF CANNULA HAD PROPERLY INSERTED IN THE INFUSION SITE (ARM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261180 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000435 PP1K02072231 10385083000114

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Male