BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3240497 · Received July 15, 2013

    Report

    Report Number
    3004464228-2013-00766
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    June 13, 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 DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. THE CUSTOMER REPORTED THAT THE CANNULA DID NOT INSERT PROPERLY. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT QUALIFICATION RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. 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 YOU GET RESULTS ABOUT 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."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE ACTIVATED A POD AND GAVE HERSELF A .5U BOLUS AT 6:35 AM ON (B)(6). SHE PROVIDED THE FOLLOWING HISTORY: TIME: 9:11 AM, BG RESULT: 155 MG/DL, CARBOHYDRATE: 77 GRAMS, BOLUS: 0.85U, 7.70U; TIME: 10:36 AM, BG RESULT: 488 MG/DL, BOLUS: 7.10U; TIME: 12:02 PM, BG RESULT: 464 MG/DL, BOLUS: 7U (MANUAL INJECTION). AT 3:44 PM, WITH A RESULT OF 469 MG/DL, SHE DEACTIVATED THE POD. WHEN SHE REMOVED IT, SHE NOTICED THAT THE CANNULA HAD NEVER INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328012 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L31097

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR