BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2944244 · Received January 9, 2013

    Report

    Report Number
    3004464228-2013-00012
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 9, 2012
    Report Date
    December 10, 2012
    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 THE KINKED CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER GUIDE 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," AND ADVISES "TO AVOID HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) CHECK YOUR BLOOD GLUCOSE AT LEAST 4-6 TIMES A DAY (WHEN YOU WAKE UP, BEFORE EACH MEAL, AND BEFORE GOING TO BED)."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WAS ACTIVATED ON (B)(6) 2012 AND HER BLOOD GLUCOSE WAS IN NORMAL RANGE FOR THE FIRST TWO DAYS SHE WORE IT. IN THE MIDDLE OF NIGHT ((B)(6) 2012, EXACT TIME NOT REPORTED), IT MEASURED 443 MG/DL, SO SHE TOOK A CORRECTION BOLUS OF INSULIN BUT DID NOT FEEL ANY BETTER. SHE REMOVED POD ON (B)(6) 2012 AT ABOUT 9:00 AM, AND OBSERVED THAT THE CANNULA WAS KINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11346 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30926

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR