BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1950992 · Received January 3, 2011

    Report

    Report Number
    3004464228-2010-01472
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    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 SMALL KETONES AND CONSISTENTLY HIGH BG LEVELS (345-486MG/DL) THAT WOULD NOT LOWER DESPITE MULTIPLE CORRECTION BOLUS ATTEMPTS. THE CUSTOMER'S MOTHER REPORTED THAT THE POD HAD INITIATED AN ALARM (THE SPECIFIC ALARM TYPE WAS NOT PROVIDED) AND STATED THAT "THE CANNULA LOOKED BENT" WHEN THE POD WAS REMOVED. 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 L30393

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other