BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3240555 · Received July 16, 2013

    Report

    Report Number
    3004464228-2013-00772
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 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 RETURNED DEVICE WAS EVALUATED AND PERFORMED AS DESIGNED DURING TESTING. NO DEFECT THAT WOULD RESULT IN THE CANNULA TO FAIL TO INSERT PROPERLY OR THE PUMP TO FAIL TO DELIVER INSULIN WAS FOUND. THE CUSTOMER REPORTED THAT THE CANNULA WAS NOT INSERTED IN THE INFUSION SITE. AN IMPROPERLY INSERTED OR DISLODGED CANNULA COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. IT CANNOT BE CONFIRMED NOR EXCLUDED THROUGH LABORATORY TESTING. 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 "BECAUSE INSULIN PODS USE ONLY RAPID-ACTING INSULIN, USERS ARE AT INCREASED RISK FOR DEVELOPING HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) IF INSULIN DELIVERY IS INTERRUPTED. IF IT IS UNTREATED, SEVERE HYPERGLYCEMIA CAN QUICKLY LEAD TO DIABETIC KETOACIDOSIS (DKA). DKA CAN CAUSE BREATHING DIFFICULTIES, SHOCK, COMA, OR DEATH. IF INSULIN DELIVERY IS INTERRUPTED FOR ANY REASON, YOU MAY NEED TO REPLACE THE MISSING INSULIN - USUALLY WITH AN INJECTION OF RAPID-ACTING INSULIN. ASK YOUR HEALTHCARE PROVIDER FOR INSTRUCTIONS ON HANDLING INTERRUPTED INSULIN DELIVERY." IT ALSO WARNS, "TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS ABOVE 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPERGLYCEMIA, 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." LOT QUALIFICATION RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE ACTIVATED A NEW POD AND GAVE HERSELF A .70U BOLUS AT 11:02 PM ON (B)(6). ON (B)(6) AT 9:09 AM, HER BLOOD GLUCOSE RESULT WAS 297 MG/DL AND SHE GAVE HERSELF A 3.70U BOLUS. AT 9:17 AM, SHE CONSUMED 84 GRAMS OF CARBOHYDRATE AND GAVE HERSELF AN 8.40U BOLUS. SHE SAID THAT SHE FELT WETNESS AT THE SITE AT THAT TIME. AT 10:01 AM, WITH A RESULT OF 429 MG/DL, SHE DEACTIVATED THE POD. SHE SAID THAT AFTER SHE REMOVED IT, SHE NOTICED THAT THE CANNULA WAS NOT INSERTED IN THE INFUSION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330439 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L31097

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR