BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3032065 · Received March 6, 2013

    Report

    Report Number
    3004464228-2013-00184
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    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

    NO PRODUCT WAS RETURNED FOR EVAL. WE ARE UNABLE TO CONFIRM ANY KINKED CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO REPORTED HYPERGLYCEMIA. NO QUALIFICATION RECORD REVIEW COULD BE CONDUCTED AS NO PRODUCT LOT NUMBER WAS REPORTED. THE OMNIPOD USER 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," "IF YOUR READING IS ABOVE 500 MG/DL, THE PDM DISPLAYS 'HIGH CHECK FOR KETONES' THIS INDICATES SEVERE HYPERGLYCEMIA (HIGH BLOOD GLUCOSE)," AND "HIGH" BLOOD GLUCOSE READINGS CAN INDICATE A POTENTIALLY SERIOUS CONDITION REQUIRING IMMEDIATE MEDICAL ATTENTION. IF LEFT UNTREATED, THIS SITUATION CAN QUICKLY LEAD TO DIABETIC KETOACIDOSIS (DKA), SHOCK, COMA, OR DEATH." IF ADVISES "TELL YOUR HEALTHCARE PROVIDER IF YOU HAVE EXTREME HIGHS OR LOWS, OR IF HIGHS OR LOWS ARE OCCURRING MORE OFTEN THAN USUAL."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE MEASURED 284 MG/DL AND THAT SHE HAS BEEN HAVING PROBLEMS WITH HIGH BG FOR THE PAST WEEK, EVEN READING "HIGH" (>500 MG/DL) ONCE. SHE HAS BEEN CHANGING PODS ABOUT ONCE A DAY BECAUSE OF THIS AND EVERY ONE HAS HAD A KINK IN THE CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96503 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR