BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 7633864 · Received June 25, 2018

    Report

    Report Number
    3004464228-2018-03893
    Event Type
    Death
    Date Received
    June 25, 2018
    Date of Event
    April 27, 2018
    Report Date
    May 31, 2018
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD EXPIRED AT HOME ON (B)(6) 2018. PARAMEDICS WERE CALLED AND RESPONDED. PATIENT REFUSED TRANSPORT TO GO THE HOSPITAL. WHEN PATIENT WAS SLEEPING, PATIENT¿S BLOOD GLUCOSE (BG) LEVELS WERE VERY ERRATIC (HIGH AND LOW). PATIENT HAD BEEN TO THE PHYSICIAN DUE TO THE ERRATIC BG LEVELS. THE PATIENT'S SPOUSE SAID THAT ADJUSTMENTS HAD BEEN MADE TO THE BASAL LEVELS TO DEAL WITH IT. PATIENT¿S SPOUSE STATED THAT THE PATIENT¿S BG LEVELS DROPPED VERY LOW PRIOR TO DEATH. THE PATIENT SUFFERED WITH POOR EYESIGHT. PATIENT WAS WEARING THE POD AT THE TIME OF DEATH. PATIENT TOOK OTHER MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478408 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 20385081120002

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death