BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 13497455 · Received February 9, 2022

    Report

    Report Number
    3004464228-2022-02375
    Event Type
    Malfunction
    Date Received
    February 9, 2022
    Date of Event
    February 6, 2022
    Report Date
    February 6, 2022
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FULLY DEPLOYED. INSPECTION OF THE NEEDLE MECHANISM AND CANNULA ASSEMBLY FOUND NO ISSUES THAT WOULD RESULT IN THE CANNULA INSERTING IMPROPERLY. THE CAUSE OF THE REPORTED IMPROPER INSERTION COULD NOT BE CONCLUSIVELY DETERMINED.

    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. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO 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 COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.

    Additional Manufacturer Narrative · 0

    H6- ADDED A150206.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED OVER 300 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. DUE TO ELEVATED BG LEVELS, PATIENT LOOKED AT THE CANNULA AND WAS UNSURE IF THE CANNULA WAS PROPERLY SEATED IN THE INFUSION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945618 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 PD1C06092151 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female