BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2022538 · Received February 16, 2011

    Report

    Report Number
    3004464228-2011-00072
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 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 DISCOLORATION INSIDE THE DEVICE, INDICATING A POSSIBLE FLUID LEAK. RESIDUAL FLUID AND CORROSION WAS FOUND AROUND THE CHASSIS WALL AND RELEASE BAR. TESTING CONFIRMED THE PRESENCE OF A LEAK IN THE CANNULA FLUID PATH. A TEAR IN THE CANNULA WAS FOUND THAT APPEARED TO HAVE OCCURRED DURING THE ASSEMBLY OF THE CANNULA INTO THE CHASSIS. 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

    A FRIEND OF THE PT REPORTED THAT SHE AWOKE TO HIGH BG LEVELS (GREATER THAN 500MG/DL) THAT LASTED OVER A THREE HOUR PERIOD. THE POD WAS REMOVED AND REPLACED AND THE PATIENT'S HEALTH CARE PROVIDER WAS CALLED. (NO CONTACT WAS MADE WITH THE HCP AT THE TIME - THEY WERE AWAITING A RETURN PHONE CALL). THE PATIENT'S HUSBAND HAD CALLED BACK IN THE AFTERNOON TO SAY THAT HER BG LEVELS "ARE COMING DOWN." 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 L30421

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other