BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3963775 · Received May 20, 2014

    Report

    Report Number
    3004464228-2014-00690
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    January 27, 2014
    Report Date
    May 14, 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 RETURNED PRODUCT WAS EVALUATED AND EVIDENCE OF AN INTERNAL LEAK WAS FOUND. THE ROOT CAUSE WAS DETERMINED TO BE A DAMAGED CANNULA. THIS MANUFACTURING DEFECT 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 THAT HER BLOOD GLUCOSE REACHED "HIGH" (> 500 MG/D) LESS THAN 24 HOURS AFTER THE POD WAS ACTIVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298259 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14810-5J L40667

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR