BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2760617 · Received September 19, 2012

    Report

    Report Number
    3004464228-2012-00459
    Event Type
    Malfunction
    Date Received
    September 19, 2012
    Date of Event
    August 20, 2012
    Report Date
    August 20, 2012
    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 CUSTOMER STATED THAT THE NEEDLE MECHANISM DID NOT PROPERLY RETRACT BACK INTO THE POD. THIS INDICATES THAT THE NEEDLE MECHANISM FAILED TO FUNCTION AS DESIGNED. SINCE THE POD WAS NOT RETURNED FOR EVALUATION, HOWEVER, NO MALFUNCTION CAN BE CONFIRMED. THE OMNIPOD USER'S GUIDE WARNS TO "CHECK THE INFUSION SITE AFTER INSERTION TO ENSURE THAT THE CANNULA WAS PROPERLY INSERTED. IT IS ALSO A GOOD IDEA TO CHECK YOUR BLOOD GLUCOSE ABOUT TWO HOURS AFTER EACH POD CHANGE AND TO CHECK THE INFUSION SITE PERIODICALLY. IF THE CANNULA IS NOT PROPERLY INSERTED, HYPERGLYCEMIA MAY RESULT." AS REPORTED, THE CUSTOMER NOTICED THE NEEDLE MECHANISM HAD NOT RETRACTED BY OBSERVING THROUGH THE CANNULA WINDOW. THIS PROMPTED THE USER TO MONITOR THEIR BG LEVELS CLOSELY AND REACT QUICKLY AND APPROPRIATELY TO ANY ISSUES. PRODUCT LOT QUALIFICATION RECORDS WERE REVIEWED AND DETERMINED TO HAVE MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER REPORTED HER SON'S BG WAS "HIGH ALL DAY," RANGING FROM 293 TO 426 MG/DL. UPON REMOVING THE POD, SHE NOTICED "THE NEEDLE HAD NEVER RETRACTED." THEY ACTIVATED A NEW POD AND ADMINISTERED CORRECTION BOLUSES AND BG BEGAN TO DECREASE. THE POD WAS "DISMANTLED" AND "IN PIECES" AND THEREFORE, NOT RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30828

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR