BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3821405 · Received April 25, 2014

    Report

    Report Number
    3004464228-2014-00546
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 29, 2014
    Report Date
    March 29, 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 DEVICE WAS NOT RETURNED FOR EVAL. THE CUSTOMER REPORTED THAT THE CANNULA WAS NOT PROPERLY INSERTED AT THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT THE CUSTOMER WAS FEELING NAUSEATED AND THAT SHE WAS VOMITING. WHEN THE POD WAS REMOVED, IT WAS NOTICED THAT THE CANNULA WAS NOT INSERTED AT THE INSERTION SITE AND WAS SITTING ON TOP OF THE PT'S SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250923 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40758

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR