BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 9846974 · Received March 18, 2020

    Report

    Report Number
    3004464228-2020-03799
    Event Type
    Malfunction
    Date Received
    March 18, 2020
    Date of Event
    March 6, 2020
    Report Date
    March 6, 2020
    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, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE. MODEL: PDM-INT2-D001-MM. PT-000002-GBR-ENG-MM-AW REV. 002 11/19. CHANGING YOUR POD. CHAPTER 3 / PAGE 49. WARNINGS: CHECK OFTEN TO MAKE SURE THAT THE POD AND SOFT CANNULA ARE SECURELY ATTACHED AND IN PLACE. A LOOSE OR DISLODGED CANNULA MAY INTERRUPT INSULIN DELIVERY. VERIFY THAT THERE IS NO WETNESS OR SCENT OF INSULIN, WHICH MAY INDICATE THAT THE CANNULA HAS DISLODGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PINK SLIDE DID NOT MOVE FORWARD AND THE CANNULA DID NOT DEPLOY AS INTENDED, INDICATING A NEEDLE MECHANISM FAILURE. THE POD WAS WORN LESS THAN AN HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314323 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR