BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 9612123 · Received January 21, 2020

    Report

    Report Number
    3004464228-2020-00692
    Event Type
    Malfunction
    Date Received
    January 21, 2020
    Date of Event
    December 19, 2019
    Report Date
    December 27, 2019
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000020
    PMA / PMN Number
    K180045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. NO LOT RELEASE RECORDS WERE REVIEWED BECAUSE NO PRODUCT LOT NUMBER WAS REPORTED. OMNIPOD DASH INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE: MODEL: 18320, 18296-ENG-AW REV B 06/18. CHANGING YOUR POD: CHAPTER 3 / PAGES 48; WARNING: CHECK THE INFUSION SITE AFTER INSERTION TO ENSURE THAT THE CANNULA WAS PROPERLY INSERTED. IF THE CANNULA IS NOT PROPERLY INSERTED, HYPERGLYCEMIA MAY RESULT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE DEPLOYED EARLY WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE. THE POD WAS NOT WORN AND PATIENT'S MOTHER REPORTED A BLOOD GLUCOSE LEVEL RANGE OF 150-198 MG/DL THROUGHOUT THE DAY; THERE WAS NO METHOD OF TREATMENT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72697 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR