BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1960200 · Received December 21, 2010

    Report

    Report Number
    3004464228-2010-01449
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 26, 2010
    Report Date
    November 26, 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. 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 CUSTOMER REPORTED THAT WITHIN FOUR HOURS OF ACTIVATING A NEW POD, SHE HAD TAKEN SICK AND WAS EXPERIENCING HIGH BG LEVELS (424 MG/DL) WITH KETONES. SHE HAS ADMINISTERED CORRECTION BOLUSES, BUT HER BG LEVELS REMAINED HIGH OVER THE FOLLOWING FIVE HOURS (365 - 440 MG/DL). HER DOCTOR WAS CONSULTED, WHO ADVISED HER TO REMOVE THE POD. 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 L30380

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR