BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 6102686 · Received November 15, 2016

    Report

    Report Number
    3004464228-2016-03664
    Event Type
    Injury
    Date Received
    November 15, 2016
    Date of Event
    October 21, 2016
    Report Date
    October 21, 2016
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120002
    PMA / PMN Number
    K122953
    Adverse Event
    Yes
    Product Problem
    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 ALLERGIC REACTION OR ER VISIT FOR BORDERLINE DIABETIC KETOACIDOSIS. 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 / 2016, CHECKING YOUR BLOOD GLUCOSE 7 / PAGES 95-96. WARNING: LOW OR 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. WARNING: 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.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT SHE HAD ALLERGIC REACTION TO THE PRODUCT AND THE ADHESIVE WAS PEELING BACK. PATIENT WENT TO THE HOSPITAL AS HER BLOOD GLUCOSE LEVEL WAS OVERS 600 MG/DL. PATIENT NOTED SHE EXPERIENCED INCREASED THIRST, HEADACHE, IRRITABILITY, INCREASED URINATION, AND NAUSEA. DOCTOR DIAGNOSED HER AS BORDERLINE DIABETIC KETOACIDOSIS (DKA). PATIENT WAS TREATED WITH THREE BAGS OF FLUID, ZOFAN, AND INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755193 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 20385081120002

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R