BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3961455 · Received May 29, 2014

    Report

    Report Number
    3004464228-2014-00738
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    December 12, 2013
    Report Date
    May 3, 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. THE USER REPORTED A DISLODGED CANNULA. THIS CONDITION COULD 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 HER BLOOD GLUCOSE REACHED 467 MG/DL AND 439 MG/DL THAN 2 DAYS AFTER THE POD WAS ACTIVATED. UPON INSPECTION SHE NOTICED THE CANNULA WAS NOT INSERTED INTO THE INFUSION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315922 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40668

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR