BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3881279 · Received May 27, 2014

    Report

    Report Number
    3004464228-2014-00718
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 20, 2014
    Report Date
    April 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 PRODUCT WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE REPORTED KINKED CANNULA OR TO DETERMINE WHETHER IT CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD'S USER GUIDE WARNS TO "TEST RESULTS GREATER THAN 250 MG/ML MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS OVER 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPERGLYCEMIA, REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT POD WAS DEACTIVATED AND SHE NOTICED THE CANNULA WAS KINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310555 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40814

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR