BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2171354 · Received July 18, 2011

    Report

    Report Number
    3004464228-2011-00359
    Event Type
    Injury
    Date Received
    July 18, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 17, 2011
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVAL. NO CONCLUSION CAN BE DRAWN WHETHER THE REPORTED CANNULA ISSUE IS DUE TO AN MFG DEFECT OR OTHER PRODUCT FAULT OR IF THE NEEDLE MECHANISM AND CANNULA FIRED CORRECTLY, BUT THE CANNULA DISLODGED DURING WEAR. QUALIFICATION RECORDS FOR THE PRODUCT LOT WERE REVIEWED; ALL RELEASE CRITERIA WERE MET. THE OMNIPOD USER'S GUIDE WARNS, "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." INSULET HAS OPENED AN INTERNAL INVESTIGATION INTO NEEDLE MECHANISM FAILURES WHICH IS STILL OPEN AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    DR. (B)(6) CALLED TO INFORM US THAT THE DEVICE WAS NOT WORKING FOR HER PT'S DAUGHTER. WHEN SPEAKING TO THE PHYSICIAN, THE DOCTOR STATED THAT THE CANNULA WAS NOT INSERTED IN THE PT'S SKIN AND THE CHILD HAD A BLOOD SUGAR LEVEL OF 495 MG/DL. WHEN THE PARENT WAS ATTEMPTING TO ACTIVATE A NEW POD, SHE FAILED TO DEACTIVATE THE POD WITH THE CANNULA UNINSERTED AND THE SECOND POD FAILED. THE PARENT JUST REMOVED THE POD AND STARTED THE PROCESS OF FILLING A NEW ONE. NO DETAILS ABOUT SPECIFIC DIAGNOSIS OR TREATMENT WERE REPORTED BY THE CALLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30475

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other