BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3961460 · Received May 29, 2014

    Report

    Report Number
    3004464228-2014-00733
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    April 27, 2014
    Report Date
    May 3, 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. THE USER REPORTED A DISLODGE CANNULA. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA IF IT OCCURRED. 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 REACHED 375 MG/DL LESS THAN 36 HOURS AFTER THE POD WAS ACTIVATED. WHILE DRESSING HER SON AFTER HIS BATH SHE REALIZED THAT THE CANNULA WAS OUT OF HIS SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315903 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION L40910

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR