BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 5698742 · Received June 3, 2016

    Report

    Report Number
    3004464228-2016-01544
    Event Type
    Death
    Date Received
    June 3, 2016
    Date of Event
    April 11, 2016
    Report Date
    June 1, 2016
    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 RETURNED PRODUCT WAS EVALUATED AND PERFORMED AS DESIGNED. NO DEFECT OR DEFICIENCY THAT WOULD RESULT IN THE REPORTED DIABETIC KETOACIDOSIS (DKA). LOT 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

    A MEDICAL EXAMINER CALLED TO REPORT THE DEATH OF A PATIENT WEARING THE OMNIPOD. THE CAUSE OF DEATH WAS IDENTIFIED AS DIABETIC KETOACIDOSIS (DKA) WITH A SECONDARY CAUSE BEING HYPERTENSIVE HEART DISEASE. THE MEDICAL EXAMINER REQUESTED THE POD BE EVALUATED TO RULE OUT A MALFUNCTION OF THE DEVICE. IT WAS NOTED THAT THE PATIENT WAS LAST KNOWN TO BE ALIVE ON (B)(6) 2016 AND FOUND DECEASED ON (B)(6) 2016 BY THE LOCAL POLICE DEPARTMENT. THE PERSONAL DIABETES MANAGER (PDM) NEEDED FOR USE WITH THE POD WAS NOT FOUND WITH THE PATIENT OR AT THE PATIENT'S HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352711 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L42225

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death