BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3851285 · Received March 26, 2014

    Report

    Report Number
    3004464228-2014-00370
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    February 22, 2014
    Report Date
    February 24, 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.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED ON (B)(6) 2014 HER SON'S BLOOD GLUCOSE, CARBOHYDRATE INTAKE AND INSULIN HISTORY. AT 20:08 THE POD WAS DEACTIVATED AND GAVE A MANUAL INJECTION OF INSULIN (AMOUNT WAS NOT PROVIDED). UPON INSPECTION SHE NOTICED THE CANNULA LOOKS A LITTLE KINKED. SHE STATED SHE WAS NOT SURE IF THE KINK HAPPENED DURING POD WEAR OR AFTER REMOVAL. SHE WAS ABLE TO ACTIVATE A NEW POD. TIME: 20:43, BG (MMOL/L): 19.7, (MG/DL): 355, BOLUS (U): 3.55.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176736 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 15880 L40730

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR