BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 15156100 · Received August 3, 2022

    Report

    Report Number
    3004464228-2022-13574
    Event Type
    Injury
    Date Received
    August 3, 2022
    Date of Event
    July 26, 2022
    Report Date
    July 27, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120057
    PMA / PMN Number
    K192659
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND HYPERGLYCEMIA. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE, COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.

    Additional Manufacturer Narrative · 0

    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 THAT THE PATIENT HAD BEEN TO THE EMERGENCY ROOM WITH HYPERGLYCEMIA. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 571 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. SYMPTOMS REPORTED INCLUDE NAUSEA, SHORT OF BREATHE, BODY ACHES, FEELING VERY COLD AND DRY HEAVES. THE PATIENT WAS DIAGNOSED WITH ACUTE HYPERGLYCEMIA. THE PATIENT WAS TREATED WITH IV (INTRAVENOUS) DRIP OF FLUIDS AND INJECTED HER WITH LISPRO. THE PATIENT WAS RELEASED THE SAME DAY. THE POD WAS STILL BEING WORN IN THE EMERGENCY ROOM. IT WAS ALSO DISCOVERED THAT THE CANNULA WAS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1904777 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18025 L72353 20385081120057

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Hospitalization