BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3850785 · Received March 20, 2014

    Report

    Report Number
    3004464228-2014-00352
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    February 20, 2014
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    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 REPORTED FAILURE OF THE NEEDLE MECHANISM TO FIRE AND DEPLOY THE CANNULA OR TO DETERMINE ITS ROOT CAUSE. LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITRIA. THE OMNIPOD USER GUIDE WARNS "CHECK THE INFUSION SITE AFTER INSERTION TO ENSURE THAT THE CANNULA WAS PROPERLY INSERTED. THE PDM WILL AUTOMATICALLY REMIND YOU TO CHECK YOUR BLOOD YOUR BLOOD GLUCOSE 1.5 HOURS AFTER EACH POD CHANGE. IF THE CANNULA IS NOT PROPERLY INSERTED, HYPERGLYCEMIA MAY RESULT. VERIFY THERE IS NO WETNESS OR SCENT OF INSULIN, WHICH MAY INDICATE THE CANNULA HAS DISLODGED". 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 ML/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER", AND IF YOUR READING IS ABOVE 500 MG/DL, THE PDM DISPLAYS "HIGH CHECK FOR KETONES!. HIS INDICATES SEVERE HYPERGLYCEMIA (HIGH BLOOD GLUCOSE). IF YOU GET A 'HIGH CHECK FOR KETONES!' READING AND FEEL SYMPTOMS SUCH AS FATIGUE, THIRST, EXCESS URINATION, OR BLURRY VISION, FOLLOW YOUR HEALTHCARE PROVIDER'S RECOMMENDTION TO TREAT HYPERGLYCEMIA."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HEARING CLICKS WHEN THE POD WAS ACTIVATED AND THOUGHT THAT THE CANNULA HAD DEPLOYED LIKE NORMAL. AT 12.:29 AM ON (B)(6) 2014, THE CUSTOMER HAD A BLOOD GLUCOSE OF 223 MG/DL, SO SHE GAVE HERSELF A 1.7 UNIT BOLUS AND WENT TO BED. WHEN SHE AWOKE AT 8:25 AM, HER BLOOD GLUCOSE READ HIGH (>500 MG/DL). SHE REMOVED THE POD AND NOTICED THAT THE CANNULA HAD NEVER DEPLOYED. SHE GAVE HERSELF A MANUAL BOLUS TO LOWER THE BLOOD GLUCOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167193 OMNIPOD INSULIN PUMP PMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40657

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR