BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 POD

    MDR report key: 17043996 · Received June 1, 2023

    Report

    Report Number
    3004464228-2023-13944
    Event Type
    Malfunction
    Date Received
    June 1, 2023
    Date of Event
    May 22, 2023
    Report Date
    May 23, 2023
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385082000020
    PMA / PMN Number
    K211575
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D4: D4 - MODEL # CHANGED FROM PT-000435 TO 18320, D4 - UNIQUE IDENTIFIER (UDI) # CHANGED FROM(B)(4) TO ((B)(4), D4 - CATALOG # CHANGED FROM POD-BLE-H1-520 TO BLE-I1-529; G4 - PMA/510(K) # CHANGED FROM K203768 TO K211575.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE ABOVE 400 MG/DL WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ARM), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A MANUAL INJECTION OF INSULIN WAS GIVEN. THE POD WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089702 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION 18320 PD1U05052221 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female