BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3964007 · Received May 22, 2014

    Report

    Report Number
    3004464228-2014-00705
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    March 24, 2014
    Report Date
    April 28, 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 DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE KINKED CANULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING BLOOD GLUCOSE LEVELS BETWEEN 250 TO 290 MG/DL. THE CUSTOMER ATTEMPTED TO BOLUS SEVERAL TIMES, BUT HER BGS WOULD NOT GO DOWN. WHEN THE POD WAS REMOVED, THE CUSTOMER NOTICED THAT THE CANNULA WAS KINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306639 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40759

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR