BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 7013546 · Received November 9, 2017

    Report

    Report Number
    3004464228-2017-06169
    Event Type
    Death
    Date Received
    November 9, 2017
    Date of Event
    October 16, 2017
    Report Date
    October 16, 2017
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120002
    PMA / PMN Number
    K122953
    Adverse Event
    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 DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED DEATH. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE: MODEL: UST400, 14421-AW REV H 01/16. CHECKING YOUR BLOOD GLUCOSE 7 / PAGE 96: WARNING: TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). WARNING: IF YOU GET RESULTS BELOW 70 MG/DL OR ABOVE 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPOGLYCEMIA OR HYPERGLYCEMIA, REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL BELOW 70 MG/DL OR ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER.

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: CORRECTED "OTHER" TO "CONSUMER"

    Description of Event or Problem · 1

    THE FATHER-IN-LAW OF AN OMNIPOD PATIENT CALLED TO REPORT PATIENT HAD PASSED AWAY AND WAS REQUESTING A REFUND FOR UNUSED PODS. DUE DILIGENCE ATTEMPTS TO REACH OUT AND OBTAIN ADDITIONAL INFORMATION SURROUNDING PATIENT'S DEATH WERE NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793900 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 20385081120002

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death