BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 11356607 · Received February 21, 2021

    Report

    Report Number
    3004464228-2021-02650
    Event Type
    Malfunction
    Date Received
    February 21, 2021
    Date of Event
    February 18, 2021
    Report Date
    February 18, 2021
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120033
    PMA / PMN Number
    K192659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. 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 · 1

    IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 358 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. PATIENT REPORTED THE POD WAS LEAKING DURING WEAR. WHEN REMOVED FROM THE INFUSION SITE (LEG), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A NEW POD WAS APPLIED AND PATIENT WAS DELIVERING A CORRECTION AT THE TIME OF REPORTING. THE PATIENT'S BLOOD GLUCOSE HISTORY IS AS FOLLOWS: BG(MG/DL) ,160, 320 "AND SOMETHING", 358.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253503 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L71106 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR