BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 5255993 · Received November 30, 2015

    Report

    Report Number
    3004464228-2015-02140
    Event Type
    Malfunction
    Date Received
    November 30, 2015
    Date of Event
    October 23, 2015
    Report Date
    November 3, 2015
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED ER VISIT FOR HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS. RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD¿S USER GUIDE WARNS TO "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 ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER," AND "IF LEFT UNTREATED, DKA CAN CAUSE BREATHING DIFFICULTIES, SHOCK, COMA, AND EVENTUALLY DEATH." IT ADVISES ¿THE EASIEST AND MOST RELIABLE WAY TO AVOID DKA IS BY CHECKING YOUR BLOOD GLUCOSE AT LEAST 4¿6 TIMES A DAY. ROUTINE CHECKS ALLOW YOU TO IDENTIFY AND TREAT HIGH BLOOD GLUCOSE BEFORE DKA DEVELOPS."

    Description of Event or Problem · 1

    CUSTOMER WAS TRANSPORTED BY AMBULANCE TO THE EMERGENCY ROOM WITH HIGH BLOOD GLUCOSE AND WAS DIAGNOSED WITH DKA. HE WAS TREATED WITH IV INSULIN, SALINE, POTASSIUM, MAGNESIUM, AND CALCIUM. THE FOLLOWING INFORMATION WAS ALSO REPORTED: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785919 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L41991

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization