BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    MDR report key: 18319573 · Received December 13, 2023

    Report

    Report Number
    3004464228-2023-35333
    Event Type
    Malfunction
    Date Received
    December 13, 2023
    Date of Event
    November 16, 2023
    Report Date
    December 11, 2023
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000020
    PMA / PMN Number
    K211575
    Product Problem
    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. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO 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 COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.

    Additional Manufacturer Narrative · 0

    CORRECTION TO D1- BRAND NAME FROM OMNIPOD 5 POD TO OMNIPOD DASH INSULIN MANAGEMENT SYSTEM. CORRECTION TO D2A- COMMON DEVICE NAME FROM ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP TO PUMP, INFUSION, INSULIN. CORRECTION TO D2B - PROCODE FROM QFG TO LZG. CORRECTION TO D(4): MODEL NO CHANGED FROM PT-000536 TO 18320. CORRECTION TO D(4): LOT NUMBER CHANGED FROM PH1K03042311 TO PD1U03032311. CORRECTION TO D(4): CATALOG NO CHANGED FROM POD-BLE-H1-525 TO BLE-I1-529. CORRECTION TO D(4): EXPIRATION DATE CHANGED FROM 9/4/2024 TO 3/3/2025. CORRECTION TO D(4): UNIQUE IDENTIFIER (UDI) # CHANGED FROM (B)(4). CORRECTION TO G(4): PMA/510(K)# FROM K203768 TO K211575. CORRECTION TO H(4): DEVICE MFG DATE CHANGED FROM 3/4/2023 TO 3/3/2023.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 20 MMOL/L (360 MG/DL) WHILE WEARING THE POD BETWEEN 25 AND 36 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (LEG), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266116 OMNIPOD DASH INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 PD1U03032311 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Male