BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1911347 · Received November 23, 2010

    Report

    Report Number
    3004464228-2010-01387
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    March 7, 2010
    Report Date
    October 25, 2010
    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 PDM'S BG METER WAS FOUND TO MALFUNCTION DUE TO THE PRESENCE OF A SIGNIFICANT AMOUNT OF DEBRIS INSIDE THE METER PORT. THE PRESENCE OF THE DEBRIS WOULD HAVE INTERFERED WITH TEST STRIPS WHEN INSERTED. AS A RESULT, THE BG METER HAD THE POTENTIAL TO PROVIDE ERRONEOUS BG READINGS, WHICH WOULD IMPAIR THE CUSTOMER'S ABILITY TO PROPERLY MONITOR HER DIABETES. DUE TO THE PRESENCE OF THE DEBRIS IN THE METER PORT, THE PDM WAS POTENTIALLY A CONTRIBUTING FACTOR TO THE CUSTOMER'S "HIGHER THAN EXPECTED" BG READINGS. THE PDM FAILURE WAS THE RESULT OF "USER NEGLIGENCE" IN PROPERLY CARING FOR THE DEVICE AND IS UNRELATED TO ANY PRODUCT OR MANUFACTURING DEFICIENCY. NOTE: IT WAS DETERMINED THAT THE CUSTOMER WAS NOT USING PROPER TECHNIQUE WHEN USING THE PDM TO TEST BG'S: HANDS WERE NOT WASHED WITH SOAP AND WATER (THE OMNIPOD USER GUIDE STATES "TO ENSURE ACCURATE RESULTS, WASH YOUR HANDS AND THE TEST SITE WITH SOAP AND WATER."); AND A FRESH LANCET WAS NOT USED TO OBTAIN BLOOD SAMPLES (THE OMNIPOD USER GUIDE INSTRUCTS THE USER TO "INSERT A NEW FREESTYLE LANCET FIRMLY INTO THE WHITE LANCET HOLDER CUP."). IMPROPER TESTING TECHNIQUE WHILE USING THE PDM COULD RESULT IN ERRONEOUS/HIGH BG READINGS AS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT THAT SHE HAD BEEN EXPERIENCING "HIGHER THAN EXPECTED BG LEVELS WITHOUT INDICATION OF ALARM." A REVIEW OF HER PDM DATA CONFIRMS A ONE HOUR PERIOD WHERE HER BG LEVELS WERE CONSISTENTLY HIGH (277-416 MG/DL). THE PDM DATA ALSO SHOWS A PERIOD OF FLUCTUATING BG LEVELS (BG LEVELS RANGED FROM 69 MG/DL UP TO 382 MG/DL WITHIN A SIX HOUR TIME FRAME, THEN BACK DOWN TO 49 MG/DL 1.5 HOURS LATER). INSULET CUSTOMER SUPPORT LEARNED THAT THE CUSTOMER WAS USING "INCORRECT TEST PROCEDURES" WHEN TAKING BG READINGS (I.E., THE CUSTOMER DOES NOT WASH HANDS WITH SOAP AND WATER AND DOES NOT USE A FRESH LANCET PRIOR TO TESTING HER LEVELS). THE PDM WILL BE RETURNED IN ORDER TO TEST THE FUNCTIONALITY OF THE BG METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 13100-2B L12079

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other