BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 6124739 · Received November 23, 2016

    Report

    Report Number
    3004464228-2016-03807
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    September 1, 2016
    Report Date
    October 28, 2016
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120002
    PMA / PMN Number
    K122953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS EVALUATED AND PERFORMED AS DESIGNED. NO KINK WAS OBSERVED IN THE CANNULA. NO MALFUNCTION OR OTHER PRODUCT CONDITIONS WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE KINKED CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE MODEL: UST400 14421-AW REV H / 2016 CHECKING YOUR BLOOD GLUCOSE 7 / PAGE 96. WARNING: TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS ABOVE 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPERGLYCEMIA, REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER.

    Description of Event or Problem · 1

    THE MOTHER REPORTED HER SON'S BLOOD GLUCOSE REACHED (300 MG/DL) AND THE CANNULA WAS KINKED. POD WORN BETWEEN 4 AND 24 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775372 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L42459 20385081120002

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR