BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    MDR report key: 17350573 · Received July 19, 2023

    Report

    Report Number
    3004464228-2023-18383
    Event Type
    Death
    Date Received
    July 19, 2023
    Date of Event
    June 22, 2023
    Report Date
    June 22, 2023
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000020
    PMA / PMN Number
    K211575
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO D1: BRAND NAME CHANGED FROM OMNIPOD 5 POD TO OMNIPOD DASH INSULIN MANAGEMENT SYSTEM. D2A: COMMON DEVICE NAME CHANGED FROM ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP TO PUMP, INFUSION, INSULIN. D2B - PROCODE CHANGED FROM QFG TO LZG. CORRECTION TO D4: CATALOG NO CHANGED FROM POD-BLE-H1-520 TO BLE-I1-529. MODEL NO CHANGED FROM PT-000435 TO 18320. CORRECTION TO G5: PMA/510(K) # CHANGED FROM K203768 TO K211575. UNIQUE IDENTIFIER (UDI) # CHANGED TO (B)(4).

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS AT HOME SLEEPING , EXPERIENCED SEVERE LOW BLOOD GLUCOSE LEVELS AND ENDED UP WITH HEART FAILURE. PARAMEDICS WERE CALLED BUT RESCUE EFFORTS WERE UNSUCCESSFUL. THE PATIENT WAS REPORTED TO BE IN KIDNEY FAILURE AND ON DIALYSIS. IT WAS REPORTED THE PATIENT WAS USING OUR PRODUCT AT THE TIME OF DEATH, HOWEVER THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION, OR USE OF THE DEVICE CONTRIBUTING TO THE PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796495 OMNIPOD DASH INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 20385082000020
    905899 OMNIPOD DASH INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male Death