BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3925154 · Received June 20, 2014

    Report

    Report Number
    3004464228-2014-00845
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 26, 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 THE CANNULA WAS NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED HER SON'S BLOOD GLUCOSE REACHED BETWEEN 19 MMOL/L (342 MG/DL) TO "HIGH" (>27.8 MMOL/L) (>500 MG/DL) LESS THAN 3 HOURS AFTER THE POD WAS ACTIVATED. UPON FURTHER INSPECTION SHE NOTICED THE CANNULA WAS NOT PROPERLY INSERTED INTO THE INFUSION SITE. SHE ALSO STATED THE PINK SLIDE INSERT WAS NOTED IN THE WINDOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363379 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 15880 L40845

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR