BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2220527 · Received July 18, 2011

    Report

    Report Number
    3004464228-2011-00367
    Event Type
    Malfunction
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL; WE ARE UNABLE TO CONFIRM ANY MALFUNCTION OR OTHER PRODUCT CONDITION THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER'S HIGH BG LEVELS. WE ARE UNABLE TO CONFIRM THE REPORTED CANNULA KINK OR WHETHER IT CONTRIBUTED TO INSUFFICIENT INSULIN DELIVERY. IN ADDITION, THERE IS NO INDICATION THAT AN OCCLUSION ALARM WAS INITIATED IN RESPONSE TO THE REPORTED CANNULA KINK, WHICH SHOULD HAVE OCCURRED IF INSULIN FLOW TO THE USER WAS OBSTRUCTED. ALTHOUGH, IT CANNOT BE CONFIRMED THROUGH EVAL, THE DEVICE IS ASSUMED TO HAVE BEEN A CONTRIBUTING FACTOR TO THE CUSTOMER'S HIGH BLOOD GLUCOSE LEVELS BASED ON THE INFO PROVIDED IN THE REPORT. QUALIFICATION RECORDS FOR THE PRODUCT LOT WERE REVIEWED; ALL CRITERIA WERE MET. THE OMNIPOD USER'S GUIDE EMPHASIZES THE IMPORTANCE OF FREQUENT BLOOD GLUCOSE MONITORING. IN THE CASE OF A "HIGH" READINGS IT RECOMMENDS, "IF YOUR READING IS ABOVE 500 MG/DL, THE PDM DISPLAYS 'HIGH CHECK FOR KETONES!' THIS INDICATES SEVERE HYPERGLYCEMIA (HIGH BLOOD GLUCOSE)...IF YOU GET A 'HIGH CHECK FOR KETONES! READING BUT HAVE NO SYMPTOMS OF HIGH BLOOD GLUCOSE, RETEST WITH A NEW STRIP. IF YOU STILL GET A 'HIGH CHECK FOR KETONES!' READING, FOLLOW YOUR HEALTHCARE PROVIDER'S RECOMMENDATION TO TREAT HYPERGLYCEMIA." ADDITIONALLY, AFTER ANY BLOOD GLUCOSE READING OVER >250 MG/DL THE USER'S GUIDE ADVISES REMOVING AND REPLACING THE DEVICE AFTER NO MORE THAN FOUR HOURS IF BLOOD GLUCOSE HAS NOT RETURNED TO TARGET RANGE BY THAT TIME.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT YESTERDAY WHEN SHE PLACED THE DEVICE (TIME UNK), HER BLOOD GLUCOSE WAS NORMAL THEN AT 3:15 PM AND ALSO AT 8:38 PM IT MEASURED "HIGH" (>500 MG/DL). AT 10:17 PM, IT WAS 430 MG/DL. THE CUSTOMER REPORTED THAT THE CANNULA LOOKS BENT AND SHE OBSERVED SMALL DROP OF BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30441

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other