BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 13681537 · Received March 7, 2022

    Report

    Report Number
    3004464228-2022-03814
    Event Type
    Malfunction
    Date Received
    March 7, 2022
    Date of Event
    December 5, 2021
    Report Date
    December 5, 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 · 0

    NO ALARMS, TIMEOUTS, NOR DRIVE STALLS WERE OBSERVED IN THE DATA. THE SOFT CANNULA WAS OBSERVED TO BE DAMAGED. IT COULD NOT BE DETERMINED WHEN THIS DAMAGE OCCURRED, NOR IF THIS DAMAGE RESULTED IN A FAILURE TO DELIVER INSULIN. 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 COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENTS BLOOD GLUCOSE LEVEL ROSE TO OVER 500 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS ON THE ABDOMEN. AS TREATMENT, A MEW POD WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1963564 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L46125 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male