BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 10246044 · Received July 8, 2020

    Report

    Report Number
    3004464228-2020-10901
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Date of Event
    June 26, 2020
    Report Date
    June 26, 2020
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120002
    PMA / PMN Number
    K122953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. 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. FOR YOUR REFERENCE, INSULET MODIFIED OUR INTERNAL INVESTIGATION FINDING CODES EFFECTIVE 25 MAY 2020 AS PART OF AN EFFORT TO IMPROVE THE CLASSIFICATION OF FINDINGS TO IMPROVE THE POWER OF TRENDING DATA AND MAKE THE FINDINGS MORE INTUITIVE. THE NEW FINDINGS CODES WILL USE THE SYSTEM OF FINDING CATEGORY (E.G. HARDWARE COMPONENT), FOLLOWED BY THE AFFECTED COMPONENT (E.G. NEEDLE), FOLLOWED BY THE CONDITION (E.G. BENT). THEREFORE YOU MAY NOTICE FINDINGS THAT APPEAR TO BE NEW OR DIFFERENT BUT IN FACT ARE JUST RENAMED FOR IMPROVED DATA VALUE. INSULET WOULD BE HAPPY TO EXPLAIN ANY MAPPING OF THE OLD TO NEW FINDING CODES IF YOU HAVE ANY QUESTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE A PATIENT WAS ACTIVATING A POD THE CANNULA DEPLOYED BEFORE PLACING IT AT THE INFUSION SITE. IN ADDITION THE CANNULA WAS FOUND TO BE BENT. THE POD WAS "NTO" WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710481 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 20385081120002

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR