BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN POD

    MDR report key: 3945313 · Received May 7, 2014

    Report

    Report Number
    3004464228-2014-00609
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 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 REPORTED ON (B)(6) 2014 HIS BLOOD GLUCOSE HISTORY. THE POD WAS DEACTIVATED, HE THEN NOTICED THE CANNULA WAS A LITTLE BENT AND THERE WAS ALSO A LITTLE BIT OF BLOOD NOTED IN THE CANNULA. HE WAS ABLE TO ACTIVATE A NEW POD AND HIS BG CAME DOWN (EXACT BG LEVELS WAS NOT PROVIDED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274820 OMNIPOD INSULIN POD PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40654

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR