BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1945379 · Received December 28, 2010

    Report

    Report Number
    3004464228-2010-01453
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 29, 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 DISCOLORATION INSIDE THE DEVICE, WHICH IS EVIDENCE OF AN INTERNAL FLUID LEAK. 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'S BG LEVELS REMAINED CONSISTENTLY HIGH (281 MG/DL - GREATER THAN 500 MG/DL) OVER THE 12 HOURS THE POD WAS WORN. MULTIPLE CORRECTION BOLUSES HAD BEEN ADMINISTERED, BUT WERE INEFFECTIVE AT LOWERING HER BG'S. THE POD WAS DEACTIVATED AND 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 30 YR Other