BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2010345 · Received February 11, 2011

    Report

    Report Number
    3004464228-2011-00058
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    December 20, 2010
    Report Date
    January 11, 2011
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE RETURNED POD FOUND EVIDENCE OF AN INTERNAL FLUID LEAK. DISCOLORATION WAS SEEN INSIDE THE DEVICE AND RESIDUAL FLUID AND CORROSION WAS FOUND ON THE SURFACES OF INTERNAL ASSEMBLIES. A LEAK TEST WAS PERFORMED, WHICH CONFIRMED THE PRESENCE OF A LEAK IN THE FLUID PATH CAUSED BY A TEAR IN THE CANNULA TUBING. THE LEAK WOULD HAVE RESULTED IN INSULIN COMING INTO CONTACT WITH INTERNAL COMPONENTS AND ASSEMBLIES, ULTIMATELY CAUSING THE DEVICE TO FAIL. A POD MALFUNCTION, THEREFORE, IS CONFIRMED TO HAVE BEEN A CONTRIBUTING FACTOR TO THE CUSTOMER'S HIGH BG LEVELS.

    Description of Event or Problem · 1

    THE REPORT INDICATED THAT THE CUSTOMER EXPERIENCED INCREASINGLY HIGH BG LEVELS (312-357MG/DL) WITH SMALL KETONES AFTER ACTIVATING A NEW POD. A CORRECTION BOLUS WAS ADMINISTERED BUT WAS UNSUCCESSFUL IN LOWERING HER LEVELS. THE POD WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30404

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other