BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 12868431 · Received November 24, 2021

    Report

    Report Number
    3004464228-2021-21188
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    November 22, 2021
    Report Date
    November 23, 2021
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000020
    PMA / PMN Number
    K192659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 400 MG/DL WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. WHEN REMOVED FROM THE INFUSION SITE (BACK), THE POD'S CANNULA WAS FOUND BENT. LIGHT BLEEDING AT THE SITE WAS ALSO REPORTED. AS TREATMENT, A NEW POD WAS APPLIED AND PATIENT DRANK A LOT OF WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764942 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 PD1K03212111 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female