BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2843686 · Received October 26, 2012

    Report

    Report Number
    3004464228-2012-00537
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    August 14, 2012
    Report Date
    September 28, 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 BE RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE BENT CONDITION OF THE 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'S 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'S MOTHER REPORTED THAT ON (B)(6) 2012 AT 3:38, PM HER SON'S BLOOD GLUCOSE MEASURED 342 MG/DL; A 4.6 UNIT INSULIN BOLUS WAS GIVEN. AT 4:05 PM, HIS BG WAS 358 MG/DL. THE DEVICE WAS REMOVED AND INSULIN WAS INJECTED MANUALLY (DOSAGE NOT REPORTED). THE CANNULA WAS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30907

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR