BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3131533 · Received May 15, 2013

    Report

    Report Number
    3004464228-2013-00449
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    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 DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION OR OTHER CONDITION. THE CUSTOMER REPORTED THAT THE CANNULA MAY NOT HAVE INSERTED PROPERLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTED TO HYPERGLYCEMIA. THE OMNIPOD USER 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," AND "TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOUR GET RESULTS ABOVE 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPER GLYCEMIA, REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER." QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN HE ACTIVATED THE POD IT DIDN'T FEEL LIKE THE CANNULA INSERTED. HE ASKED HIS WIFE TO CHECK AND SHE STATED THAT IT APPEARED TO BE INSERTED. HE THEN WENT TO LUNCH AND HIS BLOOD GLUCOSE WAS 379 MG/DL. HE GAVE A 10.3 UNIT BOLUS AND NOTICED INSULIN LEAKING FROM THE POD. HE DISCARDED IT AND GAVE 10 UNITS BY MANUAL INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216078 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L31098

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR