BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 14885305 · Received July 1, 2022

    Report

    Report Number
    3004464228-2022-11030
    Event Type
    Malfunction
    Date Received
    July 1, 2022
    Date of Event
    June 19, 2022
    Report Date
    June 23, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000020
    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

    WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR DETERMINE ITS ROOT CAUSE. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FULLY DEPLOYED. NO TIMEOUTS OR DRIVE STALLS WERE SEEN IN THE DOWNLOAD DATA. THE DATA INDICATES THAT THE POD COMPLETED BOTH THE FIRST AND SECOND PRIMING SEQUENCES BEFORE BEING DEACTIVATED. NO DAMAGES OR DEFECTS WERE OBSERVED THAT WOULD RESULT IN THE NEEDLE DEPLOYING EARLY. DURING THE INVESTIGATION THE NEEDLE MECHANISM WAS RESET TO THE NOT DEPLOYED POSITION, AND THE DEVICE FUNCTIONED PROPERLY DURING MANUAL DEPLOYMENT. ALTHOUGH NO PROBLEMS WERE FOUND, IT COULD NOT BE DETERMINED WHEN THE DEVICE DEPLOYED.D4 - LOT NO CHANGED FROM BLANK TO PD1K11232131. SERIAL NO CHANGED FROM BLANK TO (B)(6) EXPIRATION DATE CHANGED FROM BLANK TO( B)(6) UNIQUE IDENTIFIER (UDI) # CHANGED FROM (01)20385082000020 TO (01)20385082000020(11)211123(17)230523(10)PD1K11232131(21)0660954. H4 - DEVICE MFG DATE CHANGED FROM BLANK TO 11/23/2021.

    Description of Event or Problem · 0

    IT WAS REPORTED THE NEEDLE DEPLOYED EARLY, INDICATING A FAILURE OF THE NEEDLE MECHANISM. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE UNAFFECTED, AND THE POD WAS NOT WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2232875 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 PD1K11232131 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown