BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 6102680 · Received November 15, 2016

    Report

    Report Number
    3004464228-2016-03659
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    October 20, 2016
    Report Date
    October 20, 2016
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120002
    PMA / PMN Number
    K122953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE FAILED TO INSERT OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. OMNIPOD INSULIN MANAGEMENT SYSTEM  USER GUIDE: MODEL: UST400, 14421-AW REV H / 2016, USING THE POD 5 / PAGE 55, CHECKING YOUR BLOOD GLUCOSE 7 / PAGE 96. WARNING: CHECK THE INFUSION SITE AFTER INSERTION TO ENSURE THAT THE CANNULA WAS PROPERLY INSERTED. THE PDM WILL AUTOMATICALLY REMIND YOU TO CHECK 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. WARNING: 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HIGH BLOOD GLUCOSE (REPOTED RANGE OF 122-450 MG/DL) AND THAT THE CANNULA FAILED TO INSERT PROPERLY. CUSTOMER REPORTED THE CANNULA WAS SHORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754037 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L42416 20385081120002

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR