BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3883907 · Received June 12, 2014

    Report

    Report Number
    3004464228-2014-00813
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    March 15, 2014
    Report Date
    May 16, 2014
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Adverse Event
    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 BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE PATIENT'S KETOACIDOSIS AND HOSPITALIZATION. THE USER ALSO REPORTED THAT THE CANNULA WAS OUT OF THE INFUSION SITE. THIS CONDITION COULD POTENTIAL INTERRUPT INSULIN DELIVERY AND MAY LEAD TO HYPERGLYCEMIA. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE PATIENT REPORTED ON (B)(6) 2014 AT 6:15 PM SHE ACTIVATED A NEW POD AND HER BLOOD GLUCOSE, CARBOHYDRATE INTAKE AND INSULIN HISTORY IS AS FOLLOWS. AT 2:36 PM SHE WENT TO THE EMERGENCY ROOM AND UPON ARRIVAL SHE WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS. THE CANNULA WAS BENT AND IT WAS NOT PROPERLY INSERTED TO THE INFUSION SITE. THE POD WAS REMOVED AND DISCARDED. THEY PLACED HER ON AN INTRAVENOUS THERAPY OF INSULIN AND TREATED HER FOR DEHYDRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347957 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40680

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization