BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3850347 · Received March 18, 2014

    Report

    Report Number
    3004464228-2014-00344
    Event Type
    Malfunction
    Date Received
    March 18, 2014
    Date of Event
    February 12, 2014
    Report Date
    February 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 HYPERGLYCEMIA. THE USER ALSO REPORTED THAT THE CANNULA WAS OUT OF THE INFUSION SITE. THIS CONDITION WOULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA IF IT OCCURRED. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ON (B)(6) 2014 AT 05:59 SHE ACTIVATED A NEW POD. UPON DEACTIVATION SHE NOTICED THE CANNULA WAS SLIGHTLY BENT AND THE CANNULA WAS NOT INSERTED INTO THE INFUSION SITE. THERE WAS ALSO INSULIN POOLING IN THE CLEAR WINDOW OF THE POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159820 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 15880 L40729

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR