BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3925259 · Received June 25, 2014

    Report

    Report Number
    3004464228-2014-00859
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 28, 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 FIRE AND 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 REPORTED HIS BLOOD GLUCOSE REACHED 400 MG/DL LESS THAN 4 HOURS AFTER THE POD WAS ACTIVATED AND HE NOTICED THERE WAS NO PINK SLIDE INSERT NOTED IN THE WINDOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369692 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40748

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR