BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    MDR report key: 10465317 · Received August 28, 2020

    Report

    Report Number
    3004464228-2020-13776
    Event Type
    Injury
    Date Received
    August 28, 2020
    Date of Event
    August 17, 2020
    Report Date
    August 18, 2020
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000020
    PMA / PMN Number
    K192659
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED MEDICAL INTERVENTION AND HYPOGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S WIFE THAT THE PATIENT HAD LOW BLOOD GLUCOSE LEVELS OF 55 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS ON THE ABDOMEN. THE PATIENT'S WIFE STATED THAT THE THEY CALLED AN AMBULANCE. THE PARAMEDICS HAD TREATED THE PATIENT AT THE HOUSE AND PROVIDED THE PATIENT WITH SUGARY FOODS, WATER AND THEY PLACED SOMETHING ON THE PATIENT'S GUMS TO ABSORB INTO THE PATIENT'S SYSTEM. THE POD WAS THEN DISCARDED AND THE PATIENT WAS TAKEN TO THE HOSPITAL FOR PRECAUTIONARY MEASURES AND MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928960 OMNIPOD DASH INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention