BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3963981 · Received May 22, 2014

    Report

    Report Number
    3004464228-2014-00706
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 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 DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE TO CORRECTLY DEPLOY THE CANNULA OR TO DETERMINE ITS ROOT CAUSE. 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 HAD A BLOOD GLUCOSE LEVEL OF 313 MG/DL. WHEN THE MOTHER CHECKED THE INFUSION SITE, SHE NOTICED THAT THE CANNULA NEVER ENTERED THE SKIN. THE POD, WHICH WAS WORN FOR 1.5 HOURS, WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304240 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40846

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR