BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3881286 · Received February 18, 2014

    Report

    Report Number
    3004464228-2014-00193
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    January 7, 2014
    Report Date
    January 20, 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 BENT 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, THE SECOND DAT THE POD WAS WORN, HER SON'S BLOOD GLUCOSE AND INSULIN HISTORY IS AS FOLLOWS: TIME: 12:30 AM, BG (MG/DL) 273, BOLUS (U): 0.65. TIME: 1:45 AM, BG (MG/DL): 320. BOLUS (U): 0.45. AT 4:19 AM THE POD WAS DEACTIVATED AND SHE NOTICED THE CANNULA LOOKS A LITTLE BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101224 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40637

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR