BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4232702 · Received September 12, 2014

    Report

    Report Number
    3004464228-2014-01373
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    August 17, 2014
    Report Date
    August 18, 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 DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER'S FATHER REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE WAS 23.9 MMOL/L (431 MG/DL) BEFORE NOON. AFTER LUNCH, THE CUSTOMER'S BLOOD GLUCOSE READ HIGH (>27.8 MMOL/L [500 MG/DL]). WHEN THE POD WAS REMOVED, IT WAS NOTICED THAT THE CANNULA WAS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564563 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 15880 L40937

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR