BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2031428 · Received March 19, 2011

    Report

    Report Number
    3004464228-2011-00114
    Event Type
    Malfunction
    Date Received
    March 19, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    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 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. LOT QUALIFICATION TEST RESULTS FOR THIS POD LOT (L30448) REVEALED ONE FAILURE FOR AN INTERNAL POD LEAK. THE ROOT CAUSE OF THE FLUID LEAK WAS DETERMINED TO BE FROM A TEAR IN THE CANNULA. INSULET HAS INITIATED AN INTERNAL INVESTIGATION TO IDENTIFY THE ROOT CAUSE OF THIS FAILURE MODE. THE INVESTIGATION IS IN-PROCESS AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT WITHIN THE FIRST DAY OF WEARING THE POD, THE DEVICE INITIATED AN OCCLUSION ALARM. THE CUSTOMER'S MOTHER EXPLAINED THAT SHE WAS ONE WHO APPLIED THE POD. THE CUSTOMER EXPERIENCED HIGH BG LEVELS (UP TO 465 MG/DL) WHILE THE POD WAS ACTIVE. IT IS UNKNOWN WHAT METHOD OF TREATMENT WAS ADMINISTERED IN ORDER TO TREAT THE HIGH BG 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 L30448

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other