BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 16135523 · Received January 11, 2023

    Report

    Report Number
    3004464228-2023-00890
    Event Type
    Malfunction
    Date Received
    January 11, 2023
    Date of Event
    December 19, 2022
    Report Date
    December 19, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    10385083000022
    PMA / PMN Number
    K192659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H4 - DEVICE MFG DATE FROM 7/7/2022 TO 6/9/2022. CHANGED D4 CATALOG # FROM INT1-D001-MG TO PDM-H001-G-XX. CHANGED D4 ¿ SERIAL # FROM -NONE TO (B)(6). CHANGED D4 - MODEL # FROM PT-000010 TO PT-000409. CHANGED D4 - UNIQUE IDENTIFIER (UDI) # FROM (B)(4). CHANGED PDM LOT # FROM D4 - LOT # PH1K07072231 TO H000463L.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED THE REPORTED BATTERY EVENT. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 0

    A PATIENT REPORTS THEIR PERSONAL DIABETES MANAGER (PDM) BATTERY WILL NOT CHARGE. THE PATIENTS REPORTED BLOOD GLUCOSE LEVEL WAS OVER 250 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333608 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION PT-000409 H000463 10385083000022

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Female