BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1021780 · Received March 28, 2008

    Report

    Report Number
    3004464228-2008-00016
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 21, 2008
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION INDICATES THAT A RETAINER ALLOWED A COMPONENT TO MOVE WHICH PREVENTED THE PLUNGER FROM ADVANCING. THE USER IS INSTRUCTED IN THE USER GUIDE TO FREQUENTLY MONITOR THEIR BG LEVELS. BY FOLLOWING THESE RECOMMENDATIONS, THE USER WOULD BECOME AWARE OF HIGH BG LEVELS AND COULD USE ANOTHER DEVICE OR BACKUP THERAPY IF REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER'S FATHER CALLED IN AND REPORTED THAT HIS SON'S BLOOD SUGARS WERE ELEVATED. THE DEVICE WAS ACTIVATED AT 12AM AND HIS BG LEVEL WAS 193. AT 8:39 AM HIS BG MEASURED 240 AND A 6 UNIT BOLUS WAS ADMINISTERED. AT 11:16AM PDM READ HIGH (OVER 500) AND A 5.25 UNIT BOLUS WAS ADMINISTERED. BY APPROXIMATELY 1:35 PM, HIS BG MEASURED 578 AND HIS HEART RATE WAS ELEVATED. THE MEDICAL STAFF AT THE SKI LODGE STARTED AT IV AND WHEN THE AMBULANCE GOT TO THE LODGE THEY STARTED ANOTHER. AT THIS POINT, THE FATHER TOOK THE POD OFF AND ADMINISTERED 7 UNITS OF NOVOLOG VIA INJECTION. HIS SON WAS TRANSPORTED TO THE HOSPITAL VIA AMBULANCE. BY 2:35 PM BG WAS 298 BLOOD TESTS AND URINE TESTS CAME BACK NORMAL. THE FATHER STATED THAT WHEN THE POD WAS ACTIVATED ON THE 15TH HE HEARD A "SPRINGY CLICK ONCE". NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L11534

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention