BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM.

    MDR report key: 15320152 · Received August 30, 2022

    Report

    Report Number
    3004464228-2022-15662
    Event Type
    Injury
    Date Received
    August 30, 2022
    Date of Event
    August 17, 2022
    Report Date
    August 19, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120057
    PMA / PMN Number
    K192659
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 HOSPITALIZATION AND HYPOGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    CORRECTION TO D1 - BRAND NAME CHANGED FROM OMNIPOD INSULIN PUMP TO OMNIPOD INSULIN MANAGEMENT SYSTEM. CORRECTION TO D(4): CATALOG NO CHANGED FROM UNAVAILABLE TO ZXP425. CORRECTION TO G(5): PMA/510(K) # CHANGED FROM UNAVAILABLE TO K192659.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT WHILE ALREADY HOSPITALIZED FOR HYPOGLYCEMIA. THE PATIENT APPLIED THE POD AND WITHIN 4 TO 24 HOURS EXPERIENCED LOW BLOOD GLUCOSE LEVELS AND LOSS OF CONSCIOUSNESS. PATIENT WAS TREATED WITH GLUCOSE GEL, FOOD AND D50 (DEXTROSE 50%) FLUIDS INTRAVENOUSLY. THE PATIENT SPENT A TOTAL OF 4 DAYS IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143013 OMNIPOD INSULIN MANAGEMENT SYSTEM. PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18025 L72356 20385081120057

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Hospitalization