BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2901878 · Received November 21, 2012

    Report

    Report Number
    3004464228-2012-00602
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 26, 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 POD WAS NOT RETURNED FOR EVAL. WE ARE UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION OR DEFECT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. THE CUSTOMER REPORTED THAT THE CANNULA WAS NOT INSERTED INTO THE INFUSION SITE. THIS CONDITION WOULD INTERRUPT INSULIN DELIVERY AND COULD CONTRIBUTE TO HIGH BLOOD GLUCOSE. PRODUCT LOT QUALIFICATION RECORDS WERE REVIEWED AND FOUND TO HAVE MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD'S USER GUIDE WARNS TO "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, BUT DO NOT HAVE SYMPTOMS OF HYPERGLYCEMIA, REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT ARE ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER." IT 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 A "COUPLE WEEKS AGO" HER BLOOD GLUCOSE REACHED 493 MG/DL WITH KETONES OF 2.1. SHE STATED THAT THE CANNULA WAS NOT INSERTED IN THE SKIN AT THE INFUSION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30951

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR