BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3830193 · Received May 12, 2014

    Report

    Report Number
    3004464228-2014-00639
    Event Type
    Malfunction
    Date Received
    May 12, 2014
    Date of Event
    March 22, 2014
    Report Date
    April 13, 2014
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE REPORTED FAILURE OF THE NEEDLE MECHANISM TO PROPERLY DEPLOY THE CANNULA OR TO DETERMINE ITS ROOT CAUSE. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED HER SON'S BLOOD GLUCOSE, CARBOHYDRATE INTAKE AND INSULIN HISTORY. THE POD WAS THEN REMOVED AND NOTICED THE PINK SLIDE ON THE POD WAS NOT IN THE WINDOW. HE HAS BEEN ABNORMALLY ACTIVE, THERE WAS NOTHING UNUSUAL DURING THE FILLING AND SHE DOESN'T REMEMBER IF THERE WAS ANY INSULIN NOTED ON HIS SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283345 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40815

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR